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

NCT ID: NCT01959685

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-11-30

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.

Conditions

Pharmacokinetics; Tolerability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalting

Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose

Group Type: EXPERIMENTAL

Androxal

Intervention Type: DRUG

125 mg Androxal, 250 mg Androxal separated by at least 7 days

Placebo

Intervention Type: DRUG

Placebo, single dose

Interventions

Androxal

125 mg Androxal, 250 mg Androxal separated by at least 7 days

Intervention Type: DRUG

Placebo

Placebo, single dose

Intervention Type: DRUG

Other Intervention Names

Enclomiphene citrate; Sugar pill

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph S Podolski

Role: STUDY_CHAIR

Repros Therapeutics Inc.

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Countries

United States

Related Links

http://www.reprosrx.com

Sponsor corporate web site

Other Identifiers

ZA-109

Identifier Type: -

Identifier Source: org_study_id