NCT02754687

Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.

Detailed description

This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men followed on an inpatient basis to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of 11β-methyl nortestosterone dodecylcarbonate (11β-MNTDC). This single dose, dose-ranging study of 4 escalating doses will be conducted in two centers. Initially, 12 men will be enrolled in total, 6 men at each center, with a goal of having a minimum of 12 healthy male subjects completing this study (10 active drugs and 2 placebos) both in the fed and fasting states at each dose. Each of the 4 doses of 11β-MNTDC will be administered first fasting and then fed. Each of the doses of 11β-MNTDC will be administered about 28 days apart +/- 14 days with the time interval between the fasting and fed dosing will be approximately 7 days (-2/+9 days) and a 7 to 14 day washout will occur before dose escalation.

Conditions

• Healthy Men
• Male Contraception

Interventions

Type	Name	Description
DRUG	Placebo	Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
DRUG	11βmethyl nortestosterone dodecylcarbonate	Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC

Timeline

• Start date: 2016-07-14
• Primary completion: 2017-01-23
• Completion: 2017-06-05
• First posted: 2016-04-28
• Last updated: 2025-10-31

Locations

2 sites across 1 country: United States