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Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects

NCT03824678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-27

No results posted yet for this study

Summary

This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.

Degree of hepatic impairment will be determined during the Screening period by the subject's score according to Child-Pugh Classification Criteria

Conditions

  • Hepatic Impairment
  • Healthy Volunteers

Interventions

DRUG

CC-220

CC-220

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Alice Wang, MD · Celgene

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2019-06-18
Completion
2019-06-18
FDA Drug
Yes

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 NCT03824678 on ClinicalTrials.gov