NCT03298373

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

28-Day Repeat-Dose, Dose Escalation Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Healthy Men
• Male Contraception

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients.
DRUG	11β-methyl-nortestosterone-dodecylcarbonate	11β-MNTDC doses in castor oil/benzyl benzoate capsules (100 mg each) administered in 200 mg or 400 mg doses orally.

Timeline

• Start date: 2017-11-09
• Primary completion: 2019-02-05
• Completion: 2020-02-05
• First posted: 2017-10-02
• Last updated: 2019-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study