Clinical trial NCT01959685: A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
Official title: A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Tolerability
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 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;

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hrs
measure: Cmax of a Single Dose of 250 mg Androxal
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
Study officials:
affiliation: Repros Therapeutics Inc.
name: Joseph S Podolski
role: STUDY_CHAIR
References: