Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.

Phase 1

Completed

• Conditions: Hypogonadal Males
• Interventions: Drug: ABT-SLV361; Drug: placebo

• Registration Number: NCT01346319
• Lead Sponsor: Abbott

Brief Summary

Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.

Detailed Description

M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5 will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2 and 3 and 33 days for dose groups 4 and 5.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone undecanoate	ABT-SLV361	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males	During confinement	Blood sample results for testosterone

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males	During confinement	Blood sample results for testosterone undecanoate

Trial Locations

Locations (1)

Site Reference ID/Investigator# 51964; 🇺🇸 Fort Myers, Florida, United States