NCT03824678

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

A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Detailed description

Subjects will be enrolled in Groups 1 through 5 as follows: * Group 1: Approximately 8 male or female subjects with mild hepatic impairment (with a Child Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1. * Group 2: Approximately 8 male or female subjects with moderate hepatic impairment (with a Child Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2. * Group 3: Approximately 8 male or female subjects with severe hepatic impairment (with a Child Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3. * Group 4: Approximately 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in Group 2 with respect to sex, age (± 10 years), and weight (± 13.6 kg \[30 pounds\]). * Group 5: Approximately 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in Group 3 with respect to sex, age (± 10 years), and weight (± 13.6 kg \[30 pounds\]). Subjects with mild, moderate, and severe hepatic impairment and subjects with normal hepatic function may start the study in parallel.

Conditions

• Hepatic Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-220	CC-220

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-06-18
• Completion: 2019-06-18
• First posted: 2019-01-31
• Last updated: 2020-07-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study