Conditions: Human Volunteer
Keywords: Spermatogenesis in Healthy Males
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 180
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: minocycline extended release intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg/kg extended release minocycline HCL, once daily for 84 days. intervention 2: placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

Protocol document: