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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
9 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2013
Primary completion
Nov 2013
Completion
Nov 2013
First posted
10 Oct 2013 (estimated)
Last update posted
11 Aug 2014 (estimated)
Conditions
Pharmacokinetics · Tolerability

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014
  1. Ph 1

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

    NCT01959685

    Oct 2013 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AndroxalDrug
  • PlaceboDrug

Arms1

  • Experimental

    Dose escalting

    Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics

    Time frame · 24 hrs

    Registry description

    Cmax of a single dose 125 mg of Androxal

  2. Cmax of a Single Dose of 250 mg Androxal

    Time frame · 24 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 hrs

Pharmacokinetics

GroupValue (ng/dL)Spread
Up to 250 mg Androxal11.03.1
Primary outcomeMean· 24 hours

Cmax of a Single Dose of 250 mg Androxal

GroupValue (ng/dL)Spread
Up to 250 mg Androxal24.910.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Up to 250 mg AndroxalSubjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal–0 / 94 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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;

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