Pharmacokinetic Study of Testosterone Enanthate

Phase 1

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Delatestryl 200 mg IM Treatment C; Drug: QuickShot™ - 100 mg Treatment A; Drug: QuickShot™ - 50 mg Treatment B

• Registration Number: NCT01887418
• Lead Sponsor: Antares Pharma Inc.

Brief Summary

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed Description

Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-26
• Study Start: 2013-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-07-20
• Results First Submitted QC: 2015-09-23
• Results First Posted: 2015-10-21
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

• Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Exclusion Criteria

• Normal testosterone levels
• Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delatestryl 200 mg IM Treatment C	Delatestryl 200 mg IM Treatment C	Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
QuickShot™ - 100 mg Treatment A	QuickShot™ - 100 mg Treatment A	QuickShot™Testosterone - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B	QuickShot™ - 50 mg Treatment B	QuickShot™Testosterone- Auto-injector device for SC use

Primary Outcome Measures

Name	Time	Method
The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks	The area under the curve from time zero to last quantifiable concentration \[AUC (0-t)\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks	The maximum observed plasma concentration \[Cmax\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks	The average concentration \[Cavg\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST

Secondary Outcome Measures

Name	Time	Method
Number of Patients in the PK Parameter Category	6 weeks	The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE

Trial Locations

Locations (1)

Mens Health Boston; 🇺🇸 Brookline, Massachusetts, United States