A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03450109|
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Prostate||Drug: LY01005 Drug: Zoladex||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized and Open-label Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of LY01005 Versus Goserelin Comparator (ZOLADEX®) Following a Single Administration in Patients With Prostate Cancer|
|Actual Study Start Date :||December 22, 2017|
|Actual Primary Completion Date :||October 15, 2018|
|Actual Study Completion Date :||October 30, 2018|
One LY01005 3.6 mg gluteal IM injection.
One gluteal IM injection
Active Comparator: Zoladex
One Zoladex 3.6 mg subcutaneous injection into the anterior abdominal wall
One Subcutaneous injection in the abdominal wall
Other Name: Goserelin
- The bio-availability of goserelin in subjects receiving goserelin compared to Zoladex using Pharmacokinetic lab results [ Time Frame: The pharmacokinetic (PK) labs will be drawn at -30 minutes of dosing, .25, .5, 1, and 6 hours of dosing and days 7, 10, 13, 16, 19, 22, 25, 29 and 36 ]Area under the concentration-time curve (AUC) Assessment Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of gosereling from LY01005 and goserelin from Zoladex will be determined.
- The bio-availability of goserelin in subjects receiving LY01005 compared to Zoladex using Pharmacodynamic lab results [ Time Frame: The pharmacodynamic (PD) labs will be drawn at screening -30 minutes of dosing, .25, .5, 1, and 6 hours of dosing and days 2,4,7, 10, 13, 16, 19, 22, 25, 29 and 36 ]Maximum concentration (Cmax) Assessment Maximum concentration (Cmax) for the Pharmacokinetics (PK) of goserelin from LY01005 and ODV from Zoladex will be determined.
- Safety profiles of LY01005 compared to goserelin comparator after a single injection [ Time Frame: Safety parameters are collected at screening, days 0,2,4,7, 10, 13, 16, 19, 22, 25, 29,36, and follow up phone call ]Collection of adverse events throughout the study as a measure of safety and tolerability.
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): NCT03450109
|United States, Alabama|
|Pinnacle Research LLC|
|Anniston, Alabama, United States, 36207|
|United States, Florida|
|South Florida Medical Research|
|Aventura, Florida, United States, 33180|
|Clinical Research Center of Flordia|
|Pompano Beach, Florida, United States, 33060|
|Florida Urology Partners|
|Tampa, Florida, United States, 33615|
|United States, Texas|
|Urology, San Antonio|
|San Antonio, Texas, United States, 78909|