Comparison of Two Formulations of Androxal

NCT01984398 | Completed Phase 1 Results

• 1 other identifier: ZA-110
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Androxal Cmax Formulation A

  To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal

  24 hours

• Androxal Cmax Formulation B

  To determine and compare the PK parameter Cmax between two formulations of Androxal

  24 hours

Study Arms (2)

12.5 mg Androxal (formulations A and B)

EXPERIMENTAL

12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Drug: 12.5 mg Androxal Formulation A; Drug: 12.5 mg Androxal Formulation B

25 mg Androxal (formulations A and B)

EXPERIMENTAL

25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Drug: 25 mg Androxal Formulation A; Drug: 25 mg Androxal Formulation B

Interventions

12.5 mg Androxal Formulation A DRUG

Single dose of 12.5 mg Androxal formulation A

Also known as: enclomiphene citrate

12.5 mg Androxal (formulations A and B)

12.5 mg Androxal Formulation B DRUG

Single dose of 12.5 mg Androxal Formulation B

Also known as: enclomiphene citrate

12.5 mg Androxal (formulations A and B)

25 mg Androxal Formulation A DRUG

Single dose of 25 mg Androxal formulation A

Also known as: enclomiphene citrate

25 mg Androxal (formulations A and B)

25 mg Androxal Formulation B DRUG

Single dose of 25 mg Androxal formulation B

Also known as: enclomiphene citrate

25 mg Androxal (formulations A and B)

Eligibility Criteria

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

You may qualify if:

• Speaks, reads, and understands 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;
• Male, between the ages of 18-60 years;
• 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 overnight for the Day 1 and Day 6 visits;
• 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;
• 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;
• Slow Cytochrome P4502D6 (CYP2D6) metabolizer
• 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;;
• 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 (corrected QT) QTc interval prolongation;
• An employee or family member of an employee of the study site or the Sponsor.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Clinical Pharmacology of miami

Miami, Florida, 30014-3616, 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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Anna Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 31, 2013
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-05

Locations

US (1)