Healthy Men Clinical Trial
Official title:
Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.
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.
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