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

NCT02169804 | Completed Phase 1

• 1 other identifier: ZA-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics - The Cmax will be calculated.

  4 days

• Pharmacokinetics - The Tmax will be calculated.

  4 days

• Pharmacokinetics - The AUC0-24 will be calculated.

  4 days

• Pharmacokinetics - the AUC0-∞ will be calculated.

  4 days

• Pharmacokinetics - The t½ will be calculated.

  4 days

Secondary Outcomes (3)

• 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

Study Arms (2)

70 years or older

EXPERIMENTAL

Non-smoking healthy adult males \>or equal to 70 years of age.

Drug: Androxal 25 mg

Under 60 years of age

EXPERIMENTAL

Non-smoking healthy adult males\<60 years of age.

Drug: Androxal 25 mg

Interventions

Androxal 25 mg DRUG

70 years or older; Under 60 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Miami, Florida, United States

Location

MeSH Terms

Interventions

Enclomiphene

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 23, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

US (1)