Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-06 @ 6:09 AM
Study NCT ID:
NCT02820935
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
Sponsor:
Celgene Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: