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

NCT02274181 | Completed Phase 1

• 1 other identifier: ZA-112
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Percentage of Androxal excreted via the urine, feces and blood

  Determined by AMS lab by analysis of all excreted samples

  8 Days

Study Arms (1)

25 mg (approximately equivalent to [(~]) 500 nanocurie

EXPERIMENTAL

A single 25 mg (approximately equivalent to \[(\~\]) 500 nanocurie \[nCi\]) dose of \[14C\]Androxal

Drug: Androxal

Interventions

Androxal DRUG

25 mg (approximately equivalent to [(~]) 500 nanocurie

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Enclomiphene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Barbara Cook, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 24, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

US (1)