Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211545
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2019-12-24
Brief Title:
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 Open-label Study to Assess the Single Dose Pharmacokinetics and Relative Bioavailability of a Test Capsule Formulation of CC-92480 Compared to a Reference CC 92480 Capsule Formulation and the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of CC 92480 From Test and Reference Formulations in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-05
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 Phase 1 open-label randomized four-period crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States
The study will consist of a screening phase a baseline phase four treatment periods and a follow-up phone call The 4 treatment periods are divided into two pairs Period 1 and 2 and Period 3 and 4 potentially separated by an intermission during which subjects will be discharged from the research unit Periods 1 and 2 support relative bioavailability RBA estimation while Periods 3 and 4 support estimation of PPI effects
The study will consist of a screening phase a baseline phase four treatment periods and a follow-up phone call The 4 treatment periods are divided into two pairs Period 1 and 2 and Period 3 and 4 potentially separated by an intermission during which subjects will be discharged from the research unit Periods 1 and 2 support relative bioavailability RBA estimation while Periods 3 and 4 support estimation of PPI effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1242-7394 | OTHER | WHO | None |