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NCT01923870 · ClinicalTrials.gov registry record · Phase 1

Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function

A Phase 1 study, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01923870 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 19 participants.

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The verdict

NCT01923870, a Phase 1 study, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

* To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.

Interventions

  • DRUG Androxal 25 mg

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2013-08
Est. Completion 2014-01
Phase Phase 1

Sponsor

Repros Therapeutics

50 total trials

What the Registry Record Tells You About NCT01923870

The ClinicalTrials.gov registry entry for NCT01923870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Androxal 25 mg is the first listed.

NCT01923870 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01923870 about?

NCT01923870 is a clinical study titled "Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function". * To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function. * To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with hepatic impa...

What is the current status of trial NCT01923870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2013-08. Estimated completion is 2014-01.

What interventions are being tested in trial NCT01923870?

The interventions under investigation include: Androxal 25 mg (DRUG).

Who is sponsoring clinical trial NCT01923870?

This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.