28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

NCT03298373 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CCN014A
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).

Conditions

Healthy Men; Male Contraception

Keywords

Healthy Men; Male Contraception; Androgen

Outcome Measures

Primary Outcomes (19)

• Incidence of treatment emergent adverse events (safety and tolerability) of repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in sodium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in postassium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in chloride (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in bicarbonate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in fasting glucose (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in creatinine (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in calcium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in total bilirubin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in alkaline phosphatase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in alanine aminotransferase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in aspartate transaminase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in albumin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in blood urea nitrogen (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in body mass index (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in blood pressure (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in pulse (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in respiratory rate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

• Changes from baseline in QTc interval (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.

  28 days

Secondary Outcomes (8)

• Pharmacokinetics of 11β-MNTDC using AUC (0-24).

  28 days

• Pharmacodynamics of 11β-MNTDC by assessing the suppression of serum Testosterone (T) using mean values at each visit.

  28 days

• Pharmacodynamics of 11β-MNTDC by assessing the suppression of Estradiol (E2) using mean values at each visit.

  28 days

• Pharmacodynamics of 11β-MNTDC by assessing the suppression of Follicle Stimulating Hormone (FSH) using mean values at each visit.

  28 days

• Pharmacodynamics of 11β-MNTDC by assessing the suppression of Luteinizing Hormone (LH) using mean values at each visit

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients.

Drug: Placebo

11β-MNTDC

EXPERIMENTAL

11β-MNTDC capsules administered orally (200 mg or 400 mg).

Drug: 11β-methyl-nortestosterone-dodecylcarbonate

Interventions

Placebo DRUG

Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients.

Placebo

11β-methyl-nortestosterone-dodecylcarbonate DRUG

11β-MNTDC doses in castor oil/benzyl benzoate capsules (100 mg each) administered in 200 mg or 400 mg doses orally.

11β-MNTDC

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men who meet all the following criteria are eligible for enrollment in the trial:
• 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.
• to 50 years of age (inclusive) at the time of the enrollment visit.
• BMI ≤ 33 calculated as weight in kg/ (height in m2).
• No history of hormonal therapy use in the three months prior to the first screening visit.
• Subject agrees to use a recognized effective method of contraception with any female partner during the course of the study.
• Subjects agrees to refrain from donating blood or plasma during the study period and from participating in other investigational drug studies.
• Subjects agrees to refrain from excessive alcohol consumption during the study period. (No more than 15 drinks per week and no alcohol consumption within 24 hours of a study visit.)
• Subjects agrees to refrain from significant changes in their current exercise regimen during the drug exposure period.
• No known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
• In the opinion of the investigator, subject can comply with the protocol, understand and sign an informed consent and HIPAA form.

You may not qualify if:

• Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
• Men participating in another clinical trial involving an investigational drug within 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 or laboratory findings at screening.
• Elevated PSA (levels ≥ 2.5 ng/mL) at screening, per local laboratory normal values.
• Abnormal serum chemistry values at screening, per local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
• Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
• Use of androgens within 3 months before the first screening visit except for long acting, intramuscular testosterone undecanoate which will require a wash out period of 6 months prior to randomization.
• Ongoing use of body building substances including nutritional supplements.
• Systolic BP \> 135 mm Hg and Diastolic blood pressure BP \> 85 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of all measurements be used to determine eligibility.
• Clinically significant abnormal EKG or a QTc interval of \> 450 msec.
• PHQ-9 score of 15 or above.
• History of hypertension, including hypertension controlled with medication.
• Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
• Benign or malignant liver tumors, active liver disease or known non-alchoholic fatty liver disease (NAFLD)

Sponsors & Collaborators

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

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Washington Medical Center & Health Sciences

Seattle, Washington, 98195, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 2, 2017
• Study Start: November 9, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2020
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

US (2)