CompletedPhase 1

Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

United States12 participantsStarted 2016-07-14

Plain-language summary

The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.

Who can participate

Age range18 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
✓. 18 to 50 years of age (inclusive).
✓. BMI ≤ 33 calculated as weight in kg/ (height in m2).
✓. No history of hormonal therapy use in the last three months prior to the first screening visit.
✓. Subject agrees to use a recognized effective method of contraception with any female partner (i.e. at a minimum, use barrier plus and additional method of contraception) during the course of the study treatment and recovery phase.
✓. Subjects will refrain from donating blood or plasma during the study period.
✓. Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
✓. Subjects will not use cannabis or any recreational drugs at least 2 weeks before completing screening and during the study.

Exclusion criteria

✕. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
✕. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
✕. Clinically significant abnormal physical and laboratory findings at screening.
✕. Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
✕. Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
✕. Use of androgens within 2 months before first screening visit.
✕. Ongoing use of body building nutritional supplements.
✕. Systolic BP \> 135 mm Hg and Diastolic blood pressure BP \> 85 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5 - minute intervals and the mean of all measurements be considered).

What they're measuring

Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events

Timeframe: 12-20 weeks

Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in vital signs

Timeframe: 12-20 weeks

Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in lab tests

Timeframe: 12-20 weeks

Trial details

NCT IDNCT02754687

SponsorPremier Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-23

View on ClinicalTrials.gov More Healthy Men trials

Who can participate

Age range18 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
✓. 18 to 50 years of age (inclusive).
✓. BMI ≤ 33 calculated as weight in kg/ (height in m2).
✓. No history of hormonal therapy use in the last three months prior to the first screening visit.
✓. Subject agrees to use a recognized effective method of contraception with any female partner (i.e. at a minimum, use barrier plus and additional method of contraception) during the course of the study treatment and recovery phase.
✓. Subjects will refrain from donating blood or plasma during the study period.
✓. Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
✓. Subjects will not use cannabis or any recreational drugs at least 2 weeks before completing screening and during the study.

Exclusion criteria

✕. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
✕. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
✕. Clinically significant abnormal physical and laboratory findings at screening.
✕. Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
✕. Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin less than 2 mg/dL, upper limit for cholesterol less than 221 mg/dL, or upper limit for fasting triglycerides less than 201 mg/dL.
✕. Use of androgens within 2 months before first screening visit.
✕. Ongoing use of body building nutritional supplements.
✕. Systolic BP \> 135 mm Hg and Diastolic blood pressure BP \> 85 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5 - minute intervals and the mean of all measurements be considered).

What they're measuring

Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by adverse events

Timeframe: 12-20 weeks

Safety and tolerability of single dose oral administration of up to 4 escalating doses of 11-β methyl nortestosterone dodecylcarbonate (11β-MNTDC) as measured by changes from baseline in lab tests

Timeframe: 12-20 weeks