A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
Condition: Human Volunteer
Intervention: minocycline extended release; Placebo
Intervention description: 1 mg/kg extended release minocycline HCL, once daily for 84 days.; placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spermatogenesis in Healthy Males

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males at least 18 years of age

          -  Weight 45 kg - 136.36 kg (99-300 lbs)

          -  Must understand and give consent voluntarily to be in the study and to comply with
             study requirements

          -  Subjects must ejaculate between 48 and 72 hours prior to collection of the first
             specimen (Pre-Collection Ejaculation) and refrain from further ejaculation until
             Specimen 1 is collected. The second ejaculation sample Specimen 2) must be collected
             between 48 hours and 72 hours after Specimen 1. No ejaculation is permitted between
             Specimen 1 and Specimen 2

          -  Must refrain from using saunas or hot tubs during the duration of the study 168 days)

          -  Must be a non smoker

          -  Must be medically healthy as determined by the investigator physician (via medical
             history and clinical laboratory tests)

          -  Must have sperm parameters (average of Specimen 1 and Specimen 2) within clinically
             acceptable limits at screening defined as:

          -  Total sperm concentration ≥20 x 106/mL10

          -  % motile ≥50%10

          -  % normal morphology >4.4%14

        Exclusion Criteria:

          -  Known allergy/sensitivity to minocycline or any of the other drug product components

          -  Use of antacids or other dietary supplements containing aluminum, calcium, iron, or
             magnesium

          -  History of vestibular incidents including vertigo, lightheadedness, nausea, or
             vomiting within the 30 days prior to enrollment

          -  Known history of alcohol or drug dependency, significant within the past 2 years

          -  Known history or current risk of hepatic dysfunction

          -  Known history or current risk of renal dysfunction, e.g., uncontrolled diabetes

          -  Systemic lupus erythematosis (SLE) or a positive ANA at screening

          -  Receipt of any experimental drugs within 120 days prior to Study Day 0

          -  Non-LFT clinical laboratory values outside the normal range and determined to be of
             clinical significance

          -  Liver function tests greater than 1.5 times the upper limit of normal (ALT, AST, GGT)

          -  Use of tetracyclines, erythromycin within 12 weeks of Day 0