NCT02820935

Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects

A Phase 1, Open-label, Single-center Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel. A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.

Detailed description

This is a two part study to be conducted at a single study site. Both parts of the study may be conducted in parallel. A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts. Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate in a Screening phase, one baseline visit per period, one dosing phase per period, and follow-up telephone call. In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-220 in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in Period 2.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	CC-220
DRUG	Rifampin
DRUG	Itraconazole

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-07-01
• Last updated: 2016-10-18

Locations

1 site across 1 country: United States