Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males

NCT01991327 | Completed Phase 1

• 1 other identifier: ZA-106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and tolerability of Androxal will be determined in healthy male subjects administered Androxal 25 mg daily for 3 days.

Conditions

Drug-drug Interaction

Outcome Measures

Primary Outcomes (1)

• Drug-Drug Interaction

  The primary objective of this study is to assess the drug-drug interactions of Androxal with cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy male subjects administered 25 mg Androxal once daily for 3 days.

  3 days

Study Arms (2)

Androxal

EXPERIMENTAL

Androxal 25 mg capsules once a day for 7 days

Drug: Androxal

Placebo Androxal

ACTIVE COMPARATOR

Drug: Placebo

Interventions

Androxal DRUG

Also known as: enclomiphene citrate

Androxal

Placebo DRUG

Placebo Androxal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speak, read, and understand 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;
• Healthy male, between the ages of 18 and 60 years; body mass index (BMI) 19.0-29.9.
• All laboratory tests either within the normal range or assessed as not clinically significant by the Principal Investigator. Any clinically significant deviations outside of the normal range in the opinion of the Principal Investigator will require sponsor approval. A negative hepatitis B surface antigen, hepatitis C antibody or HIV antibody test result within the previous 3 months may be used instead of obtaining a screening laboratory sample for these laboratory tests;
• Ability to complete the study in accordance with the protocol.

You may not qualify if:

• Known hypersensitivity to Clomid;
• A positive hepatitis screen including hepatitis surface B antigen (HBsAg) and hepatitis C antibody;
• A positive test result for HIV;
• Positive results from a urine screen for substances of abuse;
• A recent history of alcoholism (\< 2 years) or of moderate alcohol use (greater than an average of 3 drinks per day or a total of 21 drinks per week) or use of alcohol within 24 hours prior to receiving the first dose of study medication;
• Use of any recreational drugs within the past year or a previous history of drug abuse;
• Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving study medication;
• A clinically significant electrocardiogram (ECG) abnormality;
• A history of difficulty with phlebotomy;
• Donation of blood (1 pint or more) within 30 days, or plasma within 7 days prior to receiving study medication;
• Use of any prescription drug therapy within 14 days prior to receiving study medication;
• Use of any over-the-counter (OTC) drugs for therapeutic purposes within 48 hours prior to receiving study medication; Use of dietary or herbal supplements 14 days prior to study or megavitamin supplements within 48 hours prior to receiving study medication;
• Consumption of any caffeine containing foods or beverages within 48 hours prior to receiving study medication;
• Consumption of any grapefruit or grapefruit-containing juices, vegetables from the mustard green family, and charbroiled meat within 72 hours prior to receiving study medication;
• Current smoker or user of any tobacco products that has smoked in last 30 or 60 days;

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33014, United States

Location

Related Links

• Sponsor corporate website

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: November 18, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (1)