A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

Phase 1

Completed

• Conditions: Tolerability; Pharmacokinetics
• Interventions: Drug: Androxal; Drug: Placebo

• Registration Number: NCT01959685
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Detailed Description

A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2014-06-26
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-23
• Last Update Submitted: 2014-07-23
• Results First Posted: 2014-08-11
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

• Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
• Male, between the ages of 18-60 years;
• 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 overnight for the Day 1 and Day 8 visits;
• Must be able to swallow gelatin capsules

Exclusion Criteria

• Known hypersensitivity to Clomid;
• Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
• 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;
• Slow cytochrome P450 2D6 (CYP2D6) metabolizer
• 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;
• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalting	Placebo	Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose
Dose escalting	Androxal	Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	24 hrs	Cmax of a single dose 125 mg of Androxal
Cmax of a Single Dose of 250 mg Androxal	24 hours

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States