Clinical trial NCT01984398: Comparison of Two Formulations of Androxal
Official title: A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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.

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 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.

Primary outcomes:
measure: Androxal Cmax Formulation A
timeFrame: 24 hours
measure: Androxal Cmax Formulation B
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of miami
state: Florida
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: