Comparison of Two Formulations of Androxal

A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal

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

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: 12.5 mg Androxal Formulation A; Drug: 12.5 mg Androxal Formulation B; Drug: 25 mg Androxal Formulation A; Drug: 25 mg Androxal Formulation B

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 30014-3616
      • Clinical Pharmacology of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12.5 mg Androxal (formulations A and B); 12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation	Drug: 12.5 mg Androxal Formulation A; Single dose of 12.5 mg Androxal formulation A; Other Names: enclomiphene citrate; Drug: 12.5 mg Androxal Formulation B; Single dose of 12.5 mg Androxal Formulation B; Other Names: enclomiphene citrate
Experimental: 25 mg Androxal (formulations A and B); 25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation	Drug: 25 mg Androxal Formulation A; Single dose of 25 mg Androxal formulation A; Other Names: enclomiphene citrate; Drug: 25 mg Androxal Formulation B; Single dose of 25 mg Androxal formulation B; Other Names: enclomiphene citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Androxal Cmax Formulation A	To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal	24 hours
Androxal Cmax Formulation B	To determine and compare the PK parameter Cmax between two formulations of Androxal	24 hours

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Publications and helpful links

Helpful Links

• Sponsor Corporate Website

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2013
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): December 31, 2013

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Anticoagulants; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Chelating Agents; Sequestering Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Calcium Chelating Agents; Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: ZA-110