NCT02169804CompletedPhase 1
An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Repros Therapeutics Inc.
- Enrollment
- 24
- Primary Endpoint
- Pharmacokinetics - The Cmax will be calculated.
Study Overview
Brief Summary
• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- •Male; age <60 or ≥70 years of age
- •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 for the screening visit and one overnight treatment visit after the 3rd dose of Androxal (approximately 36 hours for the treatment visit)
- •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;
- •A hematocrit >54% or a hemoglobin >17 g/dL.
- •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;
- •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;
- •Known history of HIV and/or Hepatitis B or C
- •Tobacco (nicotine products) use in the 3 months prior to the study;
- •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;
- •Previous participation in a clinical study of Androxal.
Arms & Interventions
70 years or older
Experimental
Non-smoking healthy adult males >or equal to 70 years of age.
Intervention: Androxal 25 mg (Drug)
Under 60 years of age
Experimental
Non-smoking healthy adult males<60 years of age.
Intervention: Androxal 25 mg (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics - The Cmax will be calculated.
Time Frame: 4 days
Pharmacokinetics - The Tmax will be calculated.
Time Frame: 4 days
Pharmacokinetics - The AUC0-24 will be calculated.
Time Frame: 4 days
Pharmacokinetics - the AUC0-∞ will be calculated.
Time Frame: 4 days
Pharmacokinetics - The t½ will be calculated.
Time Frame: 4 days
Secondary Outcomes
- Safety - Incidence of adverse events(4 days)
- Safety -Mean change from baseline in laboratory values(4 days)
- Safety - Mean change from baseline in vital signs(4 days)
Investigators
Similar Trials
Completed
Phase 1
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic FunctionSecondary HypogonadismNCT01923870Repros Therapeutics Inc.19
Completed
Phase 1
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal FunctionSecondary HypogonadismNCT01923857Repros Therapeutics Inc.26
Recruiting
Not Applicable
Caelyx PK.pharmacokineticscaelyxcancerNL-OMON23804Erasmus University Medical Center34
Completed
Phase 1
Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy AdultsHealthy VolunteerNCT01634191Amgen36
Terminated
Phase 1
AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine TherapyBreast CancerNCT03092635Medical University of South Carolina9