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

Repros Therapeutics

Status and phase

Completed

Phase 1

Conditions

Tolerability

Pharmacokinetics

Treatments

Drug: Androxal

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01959685

ZA-109

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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;