A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males
Overview
- Phase
- Phase 1
- Intervention
- ABT-SLV361
- Conditions
- Hypogonadal Males
- Sponsor
- Abbott
- Locations
- 1
- Primary Endpoint
- To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Testosterone undecanoate
Intervention: ABT-SLV361
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
Time Frame: During confinement
Blood sample results for testosterone
Secondary Outcomes
- To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males(During confinement)