Human Volunteer
Conditions
Keywords
Spermatogenesis in Healthy Males
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.
Interventions
DRUGminocycline extended release
1 mg/kg extended release minocycline HCL, once daily for 84 days.
DRUGPlacebo
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
Sponsors
Medicis Pharmaceutical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change From Screening in Sperm Concentration. | Baseline and 12 Weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Minocycline Extended-Release Tablets daily dose of 1 mg/kg minocycline extended-release tablets | 91 |
| Placebo daily dose of Placebo | 89 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Placebo | Total | Minocycline Extended-Release Tablets |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 180 Participants | 91 Participants |
| Age Continuous | 32.2 years STANDARD_DEVIATION 9 | 32.8 years STANDARD_DEVIATION 10 | 33.4 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 89 participants | 180 participants | 91 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 89 Participants | 180 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 91 | 27 / 89 |
| serious Total, serious adverse events | 0 / 91 | 2 / 89 |
Outcome results
Primary
Mean Percent Change From Screening in Sperm Concentration.
Time frame: Baseline and 12 Weeks
Population: The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minocycline Extended-Release Tablets | Mean Percent Change From Screening in Sperm Concentration. | 9.8 Percent change | Standard Deviation 58.3 |
| Placebo | Mean Percent Change From Screening in Sperm Concentration. | -1.3 Percent change | Standard Deviation 47.7 |