Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 3:34 AM
Study NCT ID:
NCT02045693
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2014-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction & Methadone & Buprenorphine
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325
Status:
COMPLETED
Status Verified Date:
2014-06
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 effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.
Detailed Description:
IND number: 101,943
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
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?: