An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

R

Repros Therapeutics

Status and phase

Completed
Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: Androxal 25 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02169804
ZA-111

Details and patient eligibility

About

• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

70 years or older
Experimental group
Description:
Non-smoking healthy adult males >or equal to 70 years of age.
Treatment:
Drug: Androxal 25 mg
Under 60 years of age
Experimental group
Description:
Non-smoking healthy adult males<60 years of age.
Treatment:
Drug: Androxal 25 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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