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Trial record 1 of 1 for:    TSX-011
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A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335254
Recruitment Status : Terminated (Incomplete effect)
First Posted : November 7, 2017
Results First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
TesoRx Pharma, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypogonadism
Hypogonadism, Male
Gonadal Disorders
Endocrine System Diseases
Testosterone Deficiency
Intervention Drug: TSX-011
Enrollment 9
Recruitment Details The trial enrolled nine male subjects. All subjects received treatment and completed the study. None of the enrolled/randomized subjects were withdrawn or discontinued from the study.
Pre-assignment Details  
Arm/Group Title Dose-Escalating Arm 1 Dose-Escalating Arm 2 Dose-Escalating Arm 3 Dose-Escalating Arm 4 Dose-Escalating Arm 5 Dose-Escalating Arm 6 Dose-Escalating Arm 7 Dose-Escalating Arm 8 Dose-Escalating Arm 9 Dose-Escalating Arm 10 Dose-Escalating Arm 11 Dose-Escalating Arm 12 Dose-Escalating Arm 13 Dose-Escalating Arm 14 Dose-Escalating Arm 15 Dose-Escalating Arm 16 Dose-Escalating Arm 17 Dose-Escalating Arm 18 Dose-Escalating Arm 19 Dose-Escalating Arm 20
Hide Arm/Group Description

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period Title: Period 1
Started 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 2, Day 1-15
Started 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 3, Day 16-25
Started 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 3, Day 26-30
Started 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Dose-Escalating Arm 1 Dose-Escalating Arm 2 Dose-Escalating Arm 3 Dose-Escalating Arm 4 Dose-Escalating Arm 5 Dose-Escalating Arm 6 Dose-Escalating Arm 7 Dose-Escalating Arm 8 Dose-Escalating Arm 9 Dose-Escalating Arm 10 Dose-Escalating Arm 11 Dose-Escalating Arm 12 Dose-Escalating Arm 13 Dose-Escalating Arm 14 Dose-Escalating Arm 15 Dose-Escalating Arm 16 Dose-Escalating Arm 17 Dose-Escalating Arm 18 Dose-Escalating Arm 19 Dose-Escalating Arm 20 Total
Hide Arm/Group Description

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dos 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Total of all reporting groups
Overall Number of Baseline Participants 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9
Hide Baseline Analysis Population Description
Under the same Period of the trial, only one dosing group was selected based on the adaptive dosing criteria. Therefore, some groups showed zero participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Yr
Number Analyzed 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants
51.9  (6.66) 51.9  (6.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants
Female
0
   0.0%
0
   0.0%
Male
9
 100.0%
9
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
4
  44.4%
4
  44.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
1
  11.1%
White
4
  44.4%
4
  44.4%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants
9 9
1.Primary Outcome
Title Percentage of Responders Based on Measured Total Testosterone (Cavg).
Hide Description TSX-011 responders are defined as study subjects who are able to achieve a Cavg serum total testosterone > 350 ng/dL. The percentage of responders is recorded for each treatment group within each period.
Time Frame Period 1: Up to 13 days. Period 2: 15 days. Period 3: 15 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Arm 2 to Arm 20 have zero participants due to dose adjustment based on the total testosterone levels presented.
Arm/Group Title Dose-Escalating Arm 1 Dose-Escalating Arm 2 Dose-Escalating Arm 3 Dose-Escalating Arm 4 Dose-Escalating Arm 5 Dose-Escalating Arm 6 Dose-Escalating Arm 7 Dose-Escalating Arm 8 Dose-Escalating Arm 9 Dose-Escalating Arm 10 Dose-Escalating Arm 11 Dose-Escalating Arm 12 Dose-Escalating Arm 13 Dose-Escalating Arm 14 Dose-Escalating Arm 15 Dose-Escalating Arm 16 Dose-Escalating Arm 17 Dose-Escalating Arm 18 Dose-Escalating Arm 19 Dose-Escalating Arm 20
Hide Arm/Group Description:

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 633 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 570 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 507 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 443 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 443 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 380 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose to 317 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, increase dose to 380 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose 317 mg (TU) TSX-011 twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Twice Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 317 mg (TU) TSX-011 twice daily.

Period 3, Day 26-30: Twice Daily Dose If Period 3 Day 19 total testosterone is >800 ng/dL, decrease dose to 253 mg TU twice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Thrice Daily Dose If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL, dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Period 1: Single Dose Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

Period 2: Twice Daily Dose 380 mg TSX-011 twice daily dosing period of 15 days in fed conditions. Period 3, Day 16-25: Once Daily Dose If Period 2 Day 8 total testosterone is >800 ng/dL, randomize half subjects to receive 507 mg (TU) TSX-011 once daily.

Period 3, Day 26-30: Once Daily Dose If Period 3, Day 19 total testosterone is >800 ng/dL, decrease dose to 380 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

Overall Number of Participants Analyzed 9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
Period 1 33.33
Period 2 22.22
Period 3, Day 15-26 0
Period 3, Day 26-30 0
Time Frame Adverse events presented were collected from 1 December 2017 (first subject Day 0) and 17 May 2018 (last subject visit).
Adverse Event Reporting Description An adverse event is considered any untoward or unfavorable medical occurrence associated with the subject’s participation in the study. Subjects were asked an open question such as “How have you been feeling since you were last asked?” at all visits from Day 0 to Exit.
 
Arm/Group Title Period 1: Single Dose Period 2: Twice Daily Dose Period 3, Day 16-25: Once Daily Dose Period 3, Day 16-25: Twice Daily Dose Period 3, Day 26-30: Once Daily Dose Period 3, Day 26-30: Twice Daily Dose Period 3, Day 26-30: Thrice Daily Dose
Hide Arm/Group Description

Period 1. Ascending single-dose period: 190 mg TSX-011 (fed and fasted), 380 mg TSX-011 (fed), and 570 mg TSX-011 (fed).

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

380 mg TSX-011 twice daily dosing period of 15 days in fed conditions.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

If Period 2 Day 8 total testosterone is >800 ng/dL, subjects randomized in a 1:1 ratio to receive:

  • Schedule A: 317 mg (TU) TSX-011 twice daily OR
  • Schedule B: 507 mg (TU) TSX-011 once daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

If Period 2 Day 8 total testosterone is <350 ng/dL, adjust dose to 570 mg (TU) TSX-011 twice daily.

If Period 2 Day 8 total testosterone is ≥350 ng/dL and <500 ng/dL, adjust dose to 443 mg (TU) TSX-011 twice daily.

If Period 2 Day 8 total testosterone is 500 to 800 ng/dL, inclusive, maintain 380 mg (TU) TSX-011 twice daily.

If Period 2 Day 8 total testosterone is >800 ng/dL, randomize subjects in a 1:1 ratio to receive:

  • Schedule A: 317 mg (TU) TSX-011 twice daily OR
  • Schedule B: 507 mg (TU) TSX-011 once daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL:

Dose adjust subjects on once-daily dosing from 507 mg TU daily to 570 mg TU daily.

If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose of 507 mg TU daily.

If Period 3, Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose as follows: Dose adjust subjects on once-daily dosing from 507 mg TU daily to 380 mg TU daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

If Period 3 Day 19 total testosterone is ≥350 ng/dL and <500 ng/dL:

Dose adjust subjects on twice daily dosing as follows:

  • If dose is 570 mg TU twice daily, increase to 633 mg TU twice daily.
  • If dose is 443 mg TU twice daily, increase to 507 mg TU twice daily.
  • If dose is 380 mg TU twice daily, increase to 443 mg TU twice daily.
  • If dose is 317 mg TU twice daily, increase to 380 mg TU twice daily. If Period 3 Day 19 total testosterone is 500 to 800 ng/dL inclusive, continue current dose twice daily.

If Period 3 Day 19 total testosterone is >800 ng/dL, decrease TSX-011 dose as follows:

For the twice-daily dosing group:

  • If dose is 570 mg TU twice daily, decrease to 507 mg TU twice daily.
  • If dose is 443 mg TU twice daily, decrease to 380 mg TU twice daily.
  • If dose is 380 mg TU twice daily, decrease to 317 mg TU twice daily.
  • If dose is 317 mg TU twice daily, decrease to 253 mg TU twice daily. TSX-011 are capsules with primarily Testosterone Undecanoate.

If Period 3 Day 19 total testosterone is <350 ng/dL, dose adjust subjects to 570 mg TSX-011 (TU) dosing thrice daily.

TSX-011: TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.

All-Cause Mortality
Period 1: Single Dose Period 2: Twice Daily Dose Period 3, Day 16-25: Once Daily Dose Period 3, Day 16-25: Twice Daily Dose Period 3, Day 26-30: Once Daily Dose Period 3, Day 26-30: Twice Daily Dose Period 3, Day 26-30: Thrice Daily Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)      0/0      0/9 (0.00%)      0/0      0/0      0/9 (0.00%)    
Hide Serious Adverse Events
Period 1: Single Dose Period 2: Twice Daily Dose Period 3, Day 16-25: Once Daily Dose Period 3, Day 16-25: Twice Daily Dose Period 3, Day 26-30: Once Daily Dose Period 3, Day 26-30: Twice Daily Dose Period 3, Day 26-30: Thrice Daily Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/0      0/9 (0.00%)      0/0      0/0      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period 1: Single Dose Period 2: Twice Daily Dose Period 3, Day 16-25: Once Daily Dose Period 3, Day 16-25: Twice Daily Dose Period 3, Day 26-30: Once Daily Dose Period 3, Day 26-30: Twice Daily Dose Period 3, Day 26-30: Thrice Daily Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/9 (22.22%)      1/9 (11.11%)      0/0      0/9 (0.00%)      0/0      0/0      2/9 (22.22%)    
Eye disorders               
Eye Irritation  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 1/9 (11.11%)  1
Gastrointestinal disorders               
Aphthous Ulcer  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
General disorders               
Fatigue  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 2/9 (22.22%)  2
Fever/Pyrexia  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
Injury, poisoning and procedural complications               
Insect Bite/Arthropod Bite  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
Nervous system disorders               
Lightheaded/Dizziness  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 1/9 (11.11%)  1
Headache  1  1/9 (11.11%)  1 1/9 (11.11%)  1 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Rhinorrhea  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
Cough  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
Sneezing  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/0  0 0/9 (0.00%)  0 0/0  0 0/0  0 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor will review and provide prior written consent, which shall not be unreasonably withheld.

PI will be permitted to publish in journals, theses, dissertations, or other formats of their own choosing.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Oefelein, MD, Chief Medical Officer
Organization: TesoRx Pharma, LLC
Phone: 909-595-0500 ext 104
EMail: karl@tesorx.com
Layout table for additonal information
Responsible Party: TesoRx Pharma, LLC
ClinicalTrials.gov Identifier: NCT03335254    
Other Study ID Numbers: TT-018
First Submitted: October 13, 2017
First Posted: November 7, 2017
Results First Submitted: March 4, 2019
Results First Posted: May 16, 2019
Last Update Posted: May 16, 2019