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28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men — CCN014A  

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

Clinical Trial Summary

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).

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03298373
Study type Interventional
Source Health Decisions
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 9, 2017
Completion date February 5, 2020
View Details
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