A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01959685
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief Summary

To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics; Tolerability	Drug: Androxal; Drug: Placebo	Phase 1

Detailed Description

A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalting Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose	Drug: Androxal; 125 mg Androxal, 250 mg Androxal separated by at least 7 days; Other Names: Enclomiphene citrate ; Drug: Placebo; Placebo, single dose; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [24 hrs]

   Cmax of a single dose 125 mg of Androxal

2. Cmax of a Single Dose of 250 mg Androxal [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 8 visits;

• 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;

• 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 P450 2D6 (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;

• Positive urine drug screen at the screening visit;

• 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014

Sponsors and Collaborators

• Repros Therapeutics Inc.

Investigators

• Study Chair: Joseph S Podolski, Repros Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor corporate web site

Publications

None provided.

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT01959685
• Other Study ID Numbers: ZA-109
• First Posted: Oct 10, 2013
• Last Update Posted: Aug 11, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene

Study Results

Participant Flow

Arm/Group Title	Up to 250 mg Androxal
Arm/Group Description	Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Up to 250 mg Androxal
Arm/Group Description	Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	9 100%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics
Description	Cmax of a single dose 125 mg of Androxal
Time Frame	24 hrs

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Up to 250 mg Androxal
Arm/Group Description	Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
Measure Participants	9
Mean (Standard Deviation) [ng/dL]	11.0 (3.1)

2. Primary Outcome

Title	Cmax of a Single Dose of 250 mg Androxal
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Up to 250 mg Androxal
Arm/Group Description	Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
Measure Participants	9
Mean (Standard Deviation) [ng/dL]	24.9 (10.4)

Adverse Events

Time Frame	Up to 24 hours after last dose of study drug
Adverse Event Reporting Description	As all subjects received all treatments (placebo, 125 mg Androxal, and 250 mg Androxal, (adverse events could not be separated by treatment.
Arm/Group Title	Up to 250 mg Androxal
Arm/Group Description	Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
All Cause Mortality
	Up to 250 mg Androxal
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Up to 250 mg Androxal
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Up to 250 mg Androxal
	Affected / at Risk (%)	# Events
Total	4/9 (44.4%)
General disorders
Dermatitis contact	1/9 (11.1%)
Immune system disorders
Influenza like symptoms	1/9 (11.1%)
Nervous system disorders
Headache	1/9 (11.1%)
Psychiatric disorders
Anxiety	1/9 (11.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights