Comparison of Two Formulations of Androxal

Repros Therapeutics

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: 25 mg Androxal Formulation B; Drug: 12.5 mg Androxal Formulation B; Drug: 12.5 mg Androxal Formulation A; Drug: 25 mg Androxal Formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01984398

ZA-110

Details and patient eligibility

About

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Full description

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers.

Enrollment: 16 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 6 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 P4502D6 (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;;
• 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 (corrected QT) QTc interval prolongation;
• An employee or family member of an employee of the study site or the Sponsor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

12.5 mg Androxal (formulations A and B)

Experimental group

Description:

12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Treatment:

Drug: 12.5 mg Androxal Formulation A

Drug: 12.5 mg Androxal Formulation B

25 mg Androxal (formulations A and B)

Experimental group

Description:

25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Treatment:

Drug: 25 mg Androxal Formulation A

Drug: 25 mg Androxal Formulation B