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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754687
Recruitment Status : Unknown
Verified August 2019 by Health Decisions.
Recruitment status was:  Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : August 12, 2019
Sponsor:
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
Information provided by (Responsible Party):
Health Decisions

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

Condition or disease Intervention/treatment Phase
Healthy Men Male Contraception Drug: Placebo Drug: 11βmethyl nortestosterone dodecylcarbonate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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 Name: 11β-MNTDC




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754687


Locations
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United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Health Decisions
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
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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:
Behre H M, Wang C, Handelsman D J & Nieschlag E. (2004) Pharmacology of Testosterone Preparations. In: Testosterone, Vol. Third (eds E Nieschlag & H M Behre), pp. 405-444. Cambridge University Press, Cambridge.
Heckel M J. (1939) Production of oliogspermia in a man by the use of testosterone propionate. Exl. Biol. Med. 40, 658-659.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Health Decisions
ClinicalTrials.gov Identifier: NCT02754687    
Other Study ID Numbers: CCN014
HHSN275201200002I ( Other Grant/Funding Number: NICHD Contract. This is not a grant but a contract. )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Keywords provided by Health Decisions:
male contraception
healthy men
androgen
Nortestosterone
Dodecylcarbonate
11-Beta
11β
contraception
Additional relevant MeSH terms:
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Nandrolone Decanoate
Nandrolone
Nandrolone phenpropionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents
Bone Density Conservation Agents