Healthy Men Clinical Trial
Official title:
28-Day Repeat-Dose, Dose Escalation Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).
This repeat dose, dose-ranging study will be conducted at two centers: the Los Angeles
Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington.
Two doses of 11β-MNTDC (200 mg and 400 mg) were selected for a dose-escalating 28-day repeat
dose study. Twenty subjects will complete this study at each of the 11β-MNTDC (15 on
11β-MNTDC and 5 on placebo) yielding a total of 40 completed subjects (30 on 11β-MNTDC and 10
on placebo) across both sites. Safety will be assessed in subjects receiving the lower dosage
before additional men receive the higher dose for 28 days. In addition to safety and
tolerability, suppression of serum T, calculated free T, E2, gonadotropins (LH & FSH), and
SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. The 24-hour detailed
PK of 11β-MNTDC will be assessed on Days 1 and 28. Trough levels of 11β-MNTDC will be
obtained throughout the 28-day treatment period, at 48 and 72 hours (Days 30 and 31) after
the last dose and at the End of Study visit (between Days 70-76).
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