Pharmacokinetics, Tolerability
Conditions
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.
Interventions
DRUGAndroxal
125 mg Androxal, 250 mg Androxal separated by at least 7 days
DRUGPlacebo
Placebo, single dose
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 24 hrs | Cmax of a single dose 125 mg of Androxal |
| Cmax of a Single Dose of 250 mg Androxal | 24 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Up to 250 mg Androxal Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Up to 250 mg Androxal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Cmax of a Single Dose of 250 mg Androxal
Time frame: 24 hours
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to 250 mg Androxal | Cmax of a Single Dose of 250 mg Androxal | 24.9 ng/dL | Standard Deviation 10.4 |
Primary
Pharmacokinetics
Cmax of a single dose 125 mg of Androxal
Time frame: 24 hrs
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to 250 mg Androxal | Pharmacokinetics | 11.0 ng/dL | Standard Deviation 3.1 |