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NCT01634178 · ClinicalTrials.gov registry record · Phase 1

Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

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

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
1
Study location

NCT01634178: Completed Phase 1 study of Healthy Volunteer, sponsored by Amgen.

NCT01634178 is a Phase 1 study of Healthy Volunteer that has completed, run by Amgen. The registered enrollment target is 46 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01634178, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Amgen.

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

Study Summary

The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Primary Outcome

Plasma concentrations of apremilast were determined by using a validated liquid chromatography-tandem mass spectrometry assay.

Conditions Studied

Interventions

  • DRUG Apremilast

Study Locations (1)

Texas

  • PPD Development - Austin

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2012-02-01
Est. Completion 2012-03-01
Phase Phase 1
Amgen

558 total trials

What the finished NCT01634178 record still lists

NCT01634178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (77% lower).

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

NCT01634178 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01634178 about?

NCT01634178 is a clinical study titled "Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults". The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

What is the current status of trial NCT01634178?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2012-02-01. Estimated completion is 2012-03-01.

What conditions does trial NCT01634178 study?

This clinical trial studies the following conditions: Healthy Volunteer.

What interventions are being tested in trial NCT01634178?

The interventions under investigation include: Apremilast (DRUG).

Who is sponsoring clinical trial NCT01634178?

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

Where is trial NCT01634178 being conducted?

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

Similar trials for Healthy Volunteer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01634178's enrollment target sits among peer trials

46 62nd of 112 higher than 50 of 112 other Healthy Volunteer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01634178, the US trial registry maintained by the National Library of Medicine. NCT01634178 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.