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

A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Tolerability
• Intervention / Treatment: Drug: Androxal; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalting; Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose	Drug: Androxal; 125 mg Androxal, 250 mg Androxal separated by at least 7 days; Other Names: Enclomiphene citrate; Drug: Placebo; Placebo, single dose; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	Cmax of a single dose 125 mg of Androxal	24 hrs
Cmax of a Single Dose of 250 mg Androxal		24 hours

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Publications and helpful links

Helpful Links

• Sponsor corporate web site

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: ZA-109