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An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration

NCT02274181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-03-12

No results posted yet for this study

Summary

The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to \[(\~\]) 500 nanocurie \[nCi\]) dose of \[14C\]Androxal in healthy adult male subjects.

Conditions

  • Secondary Hypogonadism

Interventions

DRUG

Androxal

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Cook, MD · Celerion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02274181 on ClinicalTrials.gov