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Trial · Interventional

CompletedPhase 1Registry data

Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

Overview

Status
Completed
Phase
Phase 1
Enrollment
12 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Open label (no masking)
Countries
Not stated
Start
Jun 2014
Primary completion
Jul 2014
Completion
Jul 2014
First posted
23 May 2014 (estimated)
Last update posted
11 Aug 2014 (estimated)
Conditions
Normal Volunteers

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

    Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

    NCT02146391

    Jun 2014 to Jul 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.

Interventions

  • Androxal 25 mg CapsulesDrug

Arms1

  • Experimental

    Androxal 25 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. • Cmax of a single dose of 25 mg of Androxal in male subjects in the fed state and fasted state.

    Time frame · 24 hour

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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; 2. Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive 3. No significant abnormal findings at the screening physical examination as evaluated by the Investigator; 4. Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator; 5. Subject is willing to remain in the clinic for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit) 6. Must be able to swallow gelatin capsules; 7. Must be willing to remain in the clinic for the treatment visits Exclusion Criteria: 1. Known hypersensitivity to Clomid; 2. Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator; 3. A hematocrit \>54% or a hemoglobin \>17 g/dL. 4. Subject with a significant organ abnormality or disease as determined by the Investigator; 5. Any medical condition that would interfere with the study as determined by the Investigator; 6. Participation in a clinical trial with investigational medication within 30 days prior to study medication administration; 7. An acute illness within 5 days of study medication administration; 8. Positive urine drug screen at the screening visit; 9. Known history of HIV and/or Hepatitis B or C 10. Tobacco (nicotine products) use in the 3 months prior to the study; 11. 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; 12. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism); 13. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation; 14. An employee or family member of an employee of the study site or the Sponsor; 15. Previous participation in a clinical study of Androxal.

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