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Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

NCT02754687•Premier Research

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men followed on an inpatient basis to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of 11β-methyl nortestosterone dodecylcarbonate (11β-MNTDC). This single dose, dose-ranging study of 4 escalating doses will be conducted in two centers. Initially, 12 men will be enrolled in total, 6 men at each center, with a goal of having a minimum of 12 healthy male subjects completing this study (10 active drugs and 2 placebos) both in the fed and fasting states at each dose. Each of the 4 doses of 11β-MNTDC will be administered first fasting and then fed. Each of the doses of 11β-MNTDC will be administered about 28 days apart +/- 14 days with the time interval between the fasting and fed dosing will be approximately 7 days (-2/+9 days) and a 7 to 14 day washout will occur before dose escalation.

Eligibility

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. 18 to 50 years of age (inclusive).
•3. BMI ≤ 33 calculated as weight in kg/ (height in m2).
•4. No history of hormonal therapy use in the last three months prior to the first screening visit.
•5. 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.
•6. Subjects will refrain from donating blood or plasma during the study period.
•7. Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
•8. Subjects will not use cannabis or any recreational drugs at least 2 weeks before completing screening and during the study.
•9. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.

Exclusion Criteria

•1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
•2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
•3. Clinically significant abnormal physical and laboratory findings at screening.
•4. Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
•5. 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.
•6. Use of androgens within 2 months before first screening visit.
•7. Ongoing use of body building nutritional supplements.
•8. 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).
•9. Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
•10. History of hypertension, including hypertension controlled with treatment.
+11 more criteria

Locations (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

University of Washington

Seattle, Washington, United States

Key Dates

Start Date

July 14, 2016

Primary Completion Date

January 23, 2017

Completion Date

June 5, 2017

Last Updated

October 31, 2025

Enrollment

ACTUAL participants

Conditions

Healthy MenMale Contraception

Interventions

Placebo

DRUG

11βmethyl nortestosterone dodecylcarbonate

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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