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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959685
• Other study ID #: ZA-109
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2013
• Last updated: July 23, 2014
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics
• Tolerability

Intervention

Drug:
• Androxal
125 mg Androxal, 250 mg Androxal separated by at least 7 days
• Placebo
Placebo, single dose

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Cmax of a single dose 125 mg of Androxal	24 hrs	No
Primary	Cmax of a Single Dose of 250 mg Androxal		24 hours	Yes

External Links

•   Sponsor corporate web site