Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men (CCN014)

August 9, 2019 updated by: Health Decisions

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.
  10. Does not meet any of the exclusion criteria.

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. Benign or malignant liver tumors; active liver disease.
  12. History of breast carcinoma.
  13. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
  14. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
  15. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
  16. A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI >33 kg/m2 as above).
  17. History of known, untreated sleep apnea.
  18. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones or study treatment compliance.
  19. Partner is known to be pregnant.
  20. Men desiring fertility within the first 24 weeks of study participation.
  21. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
Experimental: 11βmethyl nortestosterone dodecylcarbonate
11β-MNTDC in doses of 100 mg, 200 mg, 400 mg, and 800 mg
Drug: 11βmethyl nortestosterone dodecylcarbonate
Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC
Other Names:
  • 11β-MNTDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 12-20 weeks
As by adverse events
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
Time Frame: 12-20 weeks
As by changes from baseline in vital signs
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 electrocardiogram (EKG)
Time Frame: 12-20 weeks
As by changes from baseline in EKG
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 physical exams
Time Frame: 12-20 weeks
As by changes from baseline in physical exams
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
Time Frame: 12-20 weeks
As by changes from baseline in lab tests
12-20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using area under the curve (AUC)
Time Frame: 112 days
11β-MNTDC PK levels at various time points through the 112 days of treatment using AUC
112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using maximum concentration (Cmax)
Time Frame: 112 days
11β-MNTDC PK levels at various time points through the 112 days of treatment using Cmax
112 days
Pharmacokinetics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose using Time to Reach Maximum Concentration (Tmax)
Time Frame: 112 days
11β-MNTDC PK levels at various time points through the 112 days of treatment using Tmax
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Luteinizing Hormone (LH)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Follicle Stimulating Hormone (FSH)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Testosterone (T)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by free Testosterone (free T)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Dihydrotestosterone (DHT)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by estradiol (E2)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Pharmacodynamics of 11β-MNTDC after 4 escalating oral doses of 11β-MNTDC administered in a fast and fed cycle lasting approximately 28 days for each dose as measured by Sex Hormone Binding Globulin (SHBG)
Time Frame: 112 days
11β-MNTDC PD levels at various time points through the 112 days of treatment
112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using Average Concentration (Cavg)
Time Frame: 112 days
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (Cavg) after food are within 80 to 125% of those obtained at the fasting state.
112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using the area under the curve from 0-24 hours (AUC 0-24h)
Time Frame: 112 days
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (AUC0-24h) after food are within 80 to 125% of those obtained at the fasting state.
112 days
Effect of food on the pharmacokinetics of orally administered 11β-MNTDC using maximum concentration (Cmax)
Time Frame: 112 days
Comparison of pharmacokinetic measures among the single dose periods and comparison of PK parameters in the fed and fasting states will be performed with mixed model repeated measures analysis of variance (ANOVA). Evidence of lack of food effect will be concluded if ANOVA-estimated PK parameters (Cmax) after food are within 80 to 125% of those obtained at the fasting state.
112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Decisions

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Investigators

  • Principal Investigator: Christina Wang, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Principal Investigator: Stephanie Page, MD, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCN014
  • HHSN275201200002I (Other Grant/Funding Number: NICHD Contract. This is not a grant but a contract number. There is not an option to include a contract number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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