Healthy MenPhase 1CCN014ANCT03298373
28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
A Phase 1 study testing 11β-methyl-nortestosterone-dodecylcarbonate in people with Healthy Men and Male Contraception, run by Premier Research at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men, Male Contraception
- What is being tested?
- 11β-methyl-nortestosterone-dodecylcarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2017to 5 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 18 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.
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- 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.
Who cannot join
- 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.
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- 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)
- History of breast carcinoma.
- Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
- Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
- Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
- A serious systemic disease such as diabetes mellitus.
- History of known, untreated sleep apnea.
- Partner is known to be pregnant.
- Men desiring fertility within the first 24 weeks of study participation.
- Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single dose.
- Subjects taking anticonvulsants.
- Subjects taking recombinant human growth factor (HGH).
- Subjects with a hematocrit greater than 55%.
- Previous participation in this clinical trial or any trials of 11-Beta MNTDC.
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington Medical Center & Health Sciences
Seattle, Washington, 98195
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: 28-Day Repeat-Dose, Dose Escalation Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
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).
Read the detailed description
This repeat dose, dose-ranging study will be conducted at two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington.
Two doses of 11β-MNTDC (200 mg and 400 mg) were selected for a dose-escalating 28-day repeat dose study. Twenty subjects will complete this study at each of the 11β-MNTDC (15 on 11β-MNTDC and 5 on placebo) yielding a total of 40 completed subjects (30 on 11β-MNTDC and 10 on placebo) across both sites. Safety will be assessed in subjects receiving the lower dosage before additional men receive the higher dose for 28 days. In addition to safety and tolerability, suppression of serum T, calculated free T, E2, gonadotropins (LH \& FSH), and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. The 24-hour detailed PK of 11β-MNTDC will be assessed on Days 1 and 28. Trough levels of 11β-MNTDC will be obtained throughout the 28-day treatment period, at 48 and 72 hours (Days 30 and 31) after the last dose and at the End of Study visit (between Days 70-76).
- Conditions
- Healthy Men, Male Contraception
- Being tested
- Placebo, 11β-methyl-nortestosterone-dodecylcarbonate
- Keywords
- Healthy Men, Male Contraception, Androgen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients.
11β-methyl-nortestosterone-dodecylcarbonateDrug
11β-MNTDC doses in castor oil/benzyl benzoate capsules (100 mg each) administered in 200 mg or 400 mg doses orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients. Receives: Drug: Placebo |
| 11β-MNTDC | Experimental | 11β-MNTDC capsules administered orally (200 mg or 400 mg). Receives: Drug: 11β-methyl-nortestosterone-dodecylcarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (safety and tolerability) of repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in sodium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in postassium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in chloride (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in bicarbonate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in fasting glucose (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in creatinine (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in calcium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in total bilirubin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in alkaline phosphatase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in alanine aminotransferase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in aspartate transaminase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in albumin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in blood urea nitrogen (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in body mass index (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in blood pressure (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in pulse (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in respiratory rate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Changes from baseline in QTc interval (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Measured: 28 days
Secondary outcomes (8)
Pharmacokinetics of 11β-MNTDC using AUC (0-24).
Measured: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of serum Testosterone (T) using mean values at each visit.
Measured: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Estradiol (E2) using mean values at each visit.
Measured: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Follicle Stimulating Hormone (FSH) using mean values at each visit.
Measured: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Luteinizing Hormone (LH) using mean values at each visit
Measured: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Sex Hormone Binding Globulin (SHBG) using mean values at each visit.
Measured: 28 days
Changes from baseline in sexual function (safety and tolerability) with 11β-MNTDC after 28 days of dosing using the psychosexual daily questionnaire.
Measured: 28 days
Changes from baseline in mood (safety and tolerability) with 11β-MNTDC after 28 days of dosing using the Patient Health Questionnaire-9.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start9 Nov 2017
- Primary completion5 Feb 2019
- Study completion5 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298373
- Sponsor's protocol ID
- CCN014A
- Acronym
- CCN014A
- Status last verified
- Aug 2019
- First submitted
- 22 Sep 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 28-Day Repeat-Dose, Dose Escalation Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
- ClinicalTrials.gov ID
- NCT03298373
- Acronym / sponsor ID
- CCN014A / CCN014A
- Conditions
- Healthy Men, Male Contraception
- Keywords
- Healthy Men, Male Contraception, Androgen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2020 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This repeat dose, dose-ranging study will be conducted at two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington.
Two doses of 11β-MNTDC (200 mg and 400 mg) were selected for a dose-escalating 28-day repeat dose study. Twenty subjects will complete this study at each of the 11β-MNTDC (15 on 11β-MNTDC and 5 on placebo) yielding a total of 40 completed subjects (30 on 11β-MNTDC and 10 on placebo) across both sites. Safety will be assessed in subjects receiving the lower dosage before additional men receive the higher dose for 28 days. In addition to safety and tolerability, suppression of serum T, calculated free T, E2, gonadotropins (LH \& FSH), and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. The 24-hour detailed PK of 11β-MNTDC will be assessed on Days 1 and 28. Trough levels of 11β-MNTDC will be obtained throughout the 28-day treatment period, at 48 and 72 hours (Days 30 and 31) after the last dose and at the End of Study visit (between Days 70-76).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules that look like the 11β-MNTDC capsules but with no active ingredients. |
| 11β-MNTDC | Experimental | Drug: 11β-methyl-nortestosterone-dodecylcarbonate11β-MNTDC capsules administered orally (200 mg or 400 mg). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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) 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo capsules that look like the 11β-MNTDC capsules but with no active ingredients. | Drug | Placebo |
| 11β-methyl-nortestosterone-dodecylcarbonate11β-MNTDC doses in castor oil/benzyl benzoate capsules (100 mg each) administered in 200 mg or 400 mg doses orally. | Drug | 11β-MNTDC |
Primary outcome
Incidence of treatment emergent adverse events (safety and tolerability) of repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in sodium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in postassium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in chloride (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in bicarbonate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in fasting glucose (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in creatinine (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in calcium (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in total bilirubin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in alkaline phosphatase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in alanine aminotransferase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in aspartate transaminase (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in albumin (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in blood urea nitrogen (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in body mass index (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in blood pressure (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in pulse (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in respiratory rate (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
Changes from baseline in QTc interval (safety and tolerability) with repeated daily oral dosing of 11β-MNTDC.
Time frame: 28 days
8 secondary outcomes
Pharmacokinetics of 11β-MNTDC using AUC (0-24).
Time frame: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of serum Testosterone (T) using mean values at each visit.
Time frame: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Estradiol (E2) using mean values at each visit.
Time frame: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Follicle Stimulating Hormone (FSH) using mean values at each visit.
Time frame: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Luteinizing Hormone (LH) using mean values at each visit
Time frame: 28 days
Pharmacodynamics of 11β-MNTDC by assessing the suppression of Sex Hormone Binding Globulin (SHBG) using mean values at each visit.
Time frame: 28 days
Changes from baseline in sexual function (safety and tolerability) with 11β-MNTDC after 28 days of dosing using the psychosexual daily questionnaire.
Time frame: 28 days
Changes from baseline in mood (safety and tolerability) with 11β-MNTDC after 28 days of dosing using the Patient Health Questionnaire-9.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11β-methyl-nortestosterone-dodecylcarbonate in people with Healthy Men and Male Contraception, run by Premier Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (safety and tolerability) of repeated daily oral dosing of 11β-MNTDC. (time frame: 28 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.