Human Volunteer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males
Researchers want to find out how Minocycline Extended-Release Tablets affect
sperm-production in healthy males.
The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of
minocycline, compared with a placebo or inactive pill.
Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2
treatment groups with approximately 85 subjects per group. You will be treated with either
Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14
days prior to the first dose of study drug.
Required study activities include:
- Written informed consent
- Weight
- Two semen collections within 48-72 hours of one another at the screening visit and Days
84,112, 140, and 168
- Blood draws at the screening visit and Days 84, 112, 140, and 168
- Genital examination (excluding prostate) at screening and at the Day 84 and Day 112
visits
- Medical history
You will continue in the treatment phase of the study for 12 weeks.
You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of
the study, with the final study visit approximately 12 weeks after the last dose.
Participation will be for 24-weeks.
Up to 10 investigational sites will enroll subjects into the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02107833 -
Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers
|
Phase 1 |