Secondary HypogonadismPhase 1NCT02274181
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
A Phase 1 study testing Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Androxal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2015
- 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 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male subjects, 19 60 years of age, inclusive, at screening
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing
- Body mass index (BMI) ≥ 25.0 and ≤ 42.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male)
- Must agree not to donate sperm from dosing until 90 days after dosing
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds (e.g., clomiphene citrate)
- History or presence of:
Show all 25Show fewer
- Renal disease or a history of renal dysfunction;
- Liver disease or a history of liver dysfunction;
- Uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as a pituitary tumor;
- Previous history of deep vein thrombosis, pulmonary embolism or a high risk for stroke
- Conditions which are known to be exacerbated by testosterone replacement or are driven by androgen sensitivity
- Regularly have less than 1 bowel movement every 2 days
- Recent history (within 2 weeks of Day -1) of abnormal bowel habits, such as diarrhea, loose stools, or constipation
- Positive urine drug or alcohol results at screening or check in
- Positive urine cotinine at screening
- Positive results at screening for HIV, HBsAg or HCV
- Poor metabolizer for CYP2D6 based on genotyping for CYP2D6 at screening (since CYP2D6 is key enzyme for enclomiphene drug metabolism).2
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non prescription medications (including any drugs known to be significant inhibitors of CYP enzymes and/or P gp and/or OATP), herbal remedies, or vitamin supplements beginning 14 days prior to dosing of study drug and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and Milk of Magnesia (≤ 60 mL per day) may be permitted during the study
- Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to dosing of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics (PD) interaction with study drug
- Have been on a diet incompatible with the on study diet, in the opinion of the PI, within the 28 days prior to dosing of study drug, and throughout the study
- Have received radiolabeled substances or have been exposed to radiation sources over the past 12 months or is likely to receive radiation exposure or radioisotopes within the next 12 months such that participation in this study would increase their total exposure beyond the recommended levels considered safe (i.e., weighted annual limit recommended by the ICRP of 3000 mrem)
- Donation of blood or significant blood loss within 56 days prior to dosing of study drug
- Plasma donation within 7 days prior to dosing of study drug
- Participation in another clinical trial within 28 days prior to dosing of study drug. The 28 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
Read the detailed description
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroxalDrug
| Study group | Role | What they receive |
|---|---|---|
| 25 mg (approximately equivalent to [(~]) 500 nanocurie | Experimental | A single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal Receives: Drug: Androxal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Androxal excreted via the urine, feces and blood
Determined by AMS lab by analysis of all excreted samples
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HypogonadismStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Barbara Cook, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274181
- Sponsor's protocol ID
- ZA-112
- Status last verified
- Mar 2015
- First submitted
- 6 Oct 2014
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
- ClinicalTrials.gov ID
- NCT02274181
- Acronym / sponsor ID
- ZA-112
- Conditions
- Secondary Hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Dec 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Oct 2014 (estimated)
- 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.
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
Detailed description
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25 mg (approximately equivalent to [(~]) 500 nanocurie | Experimental | Drug: AndroxalA single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male subjects, 19 60 years of age, inclusive, at screening
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing
- Body mass index (BMI) ≥ 25.0 and ≤ 42.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male)
Key exclusion criteria (25 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds (e.g., clomiphene citrate)
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 |
|---|---|---|
| Androxal | Drug | 25 mg (approximately equivalent to [(~]) 500 nanocurie |
Primary outcome
Percentage of Androxal excreted via the urine, feces and blood
Time frame: 8 Days
Determined by AMS lab by analysis of all excreted samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
Related trials for Secondary Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Not yet recruitingPhase 3
SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years
Craniopharyngioma, Child
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
RecruitingPhase 2
Kisspeptin Administration Subcutaneously to Patients With IHH
Hypogonadotropic Hypogonadism
RecruitingPhase 2
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
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.
Barbara Cook, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 1 site 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 7 inclusion and 25 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: finished, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Androxal excreted via the urine, feces and blood (time frame: 8 Days). 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 Mar 2015.