Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-28 @ 2:44 AM
Study NCT ID:
NCT02103569
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2014-08
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 DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.
Detailed Description:
IND Number: 79,599 and 101,943
Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects
Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female 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?: