A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males

Conditions
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Human Volunteer

Intervention / Treatment
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* Drug: minocycline extended release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minocycline Extended-Release Tablets<br> | Drug: minocycline extended release<br>* 1 mg/kg extended release minocycline HCL, once daily for 84 days.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Screening in Sperm Concentration. |  | Baseline and 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spermatogenesis in Healthy Males