AN OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF FOOD UPON THE PHARMACOKINETICS OF ANDROXAL

Repros Therapeutics Inc.0 sites12 target enrollmentJune 2014

ConditionsNormal Volunteers

InterventionsAndroxal 25 mg Capsules

DrugsAndroxal 25 mg Capsules

Overview

Phase: Phase 1
Intervention: Androxal 25 mg Capsules
Conditions: Normal Volunteers
Sponsor: Repros Therapeutics Inc.
Enrollment: 12
Primary Endpoint: • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Repros Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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;