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

Medicis Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Human Volunteer

Treatments

Drug: Placebo

Drug: minocycline extended release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765336

MP-0104-18

IND 65,398

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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