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

NCT01959685 | Completed Phase 1 Results

• 1 other identifier: ZA-109
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics; Tolerability

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics

  Cmax of a single dose 125 mg of Androxal

  24 hrs

• Cmax of a Single Dose of 250 mg Androxal

  24 hours

Study Arms (1)

Dose escalting

EXPERIMENTAL

Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose

Drug: Androxal; Drug: Placebo

Interventions

Androxal DRUG

125 mg Androxal, 250 mg Androxal separated by at least 7 days

Also known as: Enclomiphene citrate

Dose escalting

Placebo DRUG

Placebo, single dose

Also known as: Sugar pill

Dose escalting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Related Links

• Sponsor corporate web site

MeSH Terms

Interventions

Enclomiphene; Sugars

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics Inc.

jwike@reprosrx.com

2817193402

Study Officials

• Joseph S Podolski

  Repros Therapeutics Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (1)