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).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02575209 -
Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects
|
N/A | |
Completed |
NCT00900107 -
Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals
|
N/A | |
Completed |
NCT02517775 -
Effects of Cranberry Consumption in Vascular Function in Healthy Individuals
|
N/A | |
Completed |
NCT03339167 -
Metabolic Availability of Lysine From Millet in Adult Men
|
N/A | |
Completed |
NCT01710280 -
Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia
|
N/A | |
Completed |
NCT01130948 -
Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects
|
N/A | |
Completed |
NCT01382069 -
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
|
Phase 1 | |
Recruiting |
NCT05523674 -
Effects of Warm-up Intensity and Blood Flow Restriction
|
N/A | |
Not yet recruiting |
NCT05865574 -
A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection
|
Phase 1 | |
Completed |
NCT01296997 -
Calcium Phosphate and Incretins
|
N/A | |
Completed |
NCT01293591 -
Garlic Intake And Biomarkers Of Cancer Risk
|
N/A | |
Completed |
NCT00935662 -
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
|
Phase 1 | |
Completed |
NCT01221558 -
Effects of Lycopene on Oxidative Stress and Markers of Endothelial Function Healthy Men
|
Phase 3 | |
Active, not recruiting |
NCT05825781 -
Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man
|
Phase 1 | |
Completed |
NCT02994602 -
Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males
|
Phase 1 | |
Completed |
NCT02365987 -
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety
|
N/A | |
Completed |
NCT02093169 -
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
|
Phase 1 | |
Completed |
NCT02072278 -
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
|
Phase 1 | |
Completed |
NCT03411005 -
Metabolic Availability of Lysine From Sorghum in Adult Men
|
N/A | |
Recruiting |
NCT02927210 -
Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015)
|
Phase 1 |