Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

NCT02146391 | Completed Phase 1

• 1 other identifier: ZA-107
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.

Conditions

Normal Volunteers

Outcome Measures

Primary Outcomes (1)

• • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.

  24 hour

Study Arms (1)

Androxal 25 mg

EXPERIMENTAL

Drug: Androxal 25 mg Capsules

Interventions

Androxal 25 mg Capsules DRUG

Androxal 25 mg

Eligibility Criteria

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

You may qualify if:

• Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
• Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive
• No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
• Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
• Subject is willing to remain in the clinic for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit)
• Must be able to swallow gelatin capsules;
• Must be willing to remain in the clinic for the treatment visits

You may not qualify if:

• Known hypersensitivity to Clomid;
• Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
• A hematocrit \>54% or a hemoglobin \>17 g/dL.
• Subject with a significant organ abnormality or disease as determined by the Investigator;
• Any medical condition that would interfere with the study as determined by the Investigator;
• Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
• An acute illness within 5 days of study medication administration;
• Positive urine drug screen at the screening visit;
• Known history of HIV and/or Hepatitis B or C
• Tobacco (nicotine products) use in the 3 months prior to the study;
• A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
• History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
• History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
• An employee or family member of an employee of the study site or the Sponsor;
• Previous participation in a clinical study of Androxal.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

MeSH Terms

Interventions

Enclomiphene

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08