Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-08 @ 8:12 AM
Study NCT ID:
NCT02095860
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2014-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
Detailed Description:
IND Number: 100,932/79,599/101,943
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
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?: