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NCT01561963 · ClinicalTrials.gov registry record · Phase 1

A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

A Phase 1 study of Healthy Subjects, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
1
Study location

NCT01561963 is a Phase 1 study of Healthy Subjects that has completed, run by Amgen. The registered enrollment target is 21 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01561963, a Phase 1 study of Healthy Subjects, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Conditions Studied

Interventions

  • DRUG Apremilast
  • DRUG Rifampin Oral Capsules
  • DRUG Rifampin IV Solution

Study Locations (1)

Kansas

  • Quintiles - Overland Park

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-02-01
Est. Completion 2012-04-01
Phase Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01561963

The ClinicalTrials.gov registry entry for NCT01561963 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (84% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 3 interventions - of which Apremilast is the first listed.

NCT01561963 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT01561963 about?

NCT01561963 is a clinical study titled "A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast". The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

What is the current status of trial NCT01561963?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-02-01. Estimated completion is 2012-04-01.

What conditions does trial NCT01561963 study?

This clinical trial studies the following conditions: Healthy Subjects.

What interventions are being tested in trial NCT01561963?

The interventions under investigation include: Apremilast (DRUG), Rifampin Oral Capsules (DRUG), Rifampin IV Solution (DRUG).

Who is sponsoring clinical trial NCT01561963?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01561963 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.