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NCT03742882 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects

A Phase 1 study, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT03742882 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 40 participants.

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The verdict

NCT03742882, a Phase 1 study, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.

Interventions

  • DRUG CC-90001

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-12-06
Est. Completion 2019-06-10
Phase Phase 1

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT03742882

The ClinicalTrials.gov registry entry for NCT03742882 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which CC-90001 is the first listed.

NCT03742882 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03742882 about?

NCT03742882 is a clinical study titled "A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects". This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening b...

What is the current status of trial NCT03742882?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-12-06. Estimated completion is 2019-06-10.

What interventions are being tested in trial NCT03742882?

The interventions under investigation include: CC-90001 (DRUG).

Who is sponsoring clinical trial NCT03742882?

This trial is sponsored by Celgene, which has 308 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.