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A Bioequivalence Study of Testosterone Cypionate 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: NCT03792477
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.

Condition or disease Intervention/treatment Phase
Hypogonadism Biological: Test formulation Biological: Reference formulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS
Actual Study Start Date : January 19, 2019
Actual Primary Completion Date : April 2, 2020
Actual Study Completion Date : April 2, 2020


Arm Intervention/treatment
Experimental: Part 1: Treatment A
Single 200mg IM testosterone cypionate solution (Test formulation)
Biological: Test formulation
A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).

Active Comparator: Part 1: Treatment B
Single 200 mg IM testosterone cypionate solution (Reference formulation)
Biological: Reference formulation
A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).

Experimental: Part 2: Treatment A
Single 200 mg IM testosterone cypionate solution (Test formulation)
Biological: Test formulation
A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).

Active Comparator: Part 2: Treatment B
Single 200 mg IM testosterone cypionate solution (Reference formulation)
Biological: Reference formulation
A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).




Primary Outcome Measures :
  1. Part 1: Area Under the Curve From Time Zero To Extrapolaged Infinite Time (AUCinf) of total testosterone (baseline corrected) [ Time Frame: 0 (pre-dose) 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, and 480 hours post-dose ]
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  2. Part 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of total testosterone (baseline corrected) [ Time Frame: 0, 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, 480 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  3. Part 1: Maximum Observed Plasma Concentration (Cmax) of total testosterone (baseline corrected) [ Time Frame: 0, 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, and 480 hours post-dose ]
    Maximum Observed Plasma Concentration

  4. Part 2: Area Under the Curve From Time Zero To Extrapolaged Infinite Time (AUCinf) of total testosterone (baseline corrected) [ Time Frame: 0 (pre-dose) 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, and 480 hours post-dose ]
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  5. Part 2: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of total testosterone (baseline corrected) [ Time Frame: 0, 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, 480 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  6. Part 2: Maximum Observed Plasma Concentration (Cmax) of total testosterone (baseline corrected) [ Time Frame: 0, 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336, and 480 hours post-dose ]
    Maximum Observed Plasma Concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Hypogonadal male subjects who, at the time of screening, are otherwise healthy and between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.

    Hypogonadism is defined as serum testosterone levels below 2.5 ng/mL (250 ng/dL).

  2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
  3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  2. Subjects who are currently being treated for hypogonadism. This is defined as either patients who have received a testosterone injectable product within the past 3 months or have used a transdermal or gel product within the past 2 weeks.
  3. A positive urine drug test.
  4. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
  5. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  6. Screening supine BP greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
  7. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
  8. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level greater than or equal to 3 times the upper limit of normal (ULN).
    • Total bilirubin level greater than or equal to 1.5 times the ULN; subject with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is less than or equal to ULN.
  9. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol [Contraception (Section 4.3.4)] for the duration of the study and for at least 45 days after the last dose of investigational product.
  10. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of greater than or equal to 1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
  11. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  12. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  13. History of sensitivity to heparin or heparin induced thrombocytopenia.
  14. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
  15. Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  16. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  17. Subjects with carcinoma of the breast.
  18. Subjects with known or suspected carcinoma of the prostate gland.
  19. Subjects who are hypersensitive to testosterone cypionate or its inactive ingredients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792477


Locations
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United States, Florida
Avail Clinical Research
DeLand, Florida, United States, 32720
Syneos Health
Miami, Florida, United States, 33136
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03792477    
Other Study ID Numbers: B5341002
DEPO-T BE STUDY ( Other Identifier: Alias Study Number )
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases