Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-31 @ 8:13 PM
Study NCT ID:
NCT01830205
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment
Status:
COMPLETED
Status Verified Date:
2015-11
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 renal function impairment on the single dose pharmacokinetics of Daclatasvir.
Detailed Description:
Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study
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?: