Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin

NCT ID: NCT02104843

Last Updated: 2014-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-05-31

Brief Summary

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The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

Detailed Description

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IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin

Treatment A: Rosuvastatin tablet orally on specified days

Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days

Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days

Group Type EXPERIMENTAL

Daclatasvir, Asunaprevir and BMS-791325 FDC

Intervention Type DRUG

BMS-791325

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Interventions

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Daclatasvir, Asunaprevir and BMS-791325 FDC

Intervention Type DRUG

BMS-791325

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor®

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
* Females must be of non-childbearing potential

Exclusion Criteria

* Women of childbearing potential
* Any significant acute or chronic medical condition
* Inability to tolerate oral medications
* Inability to be venipunctured and/or tolerate venous access
* Abnormal liver function tests
* Current or recent (within 3 months of dosing) gastrointestinal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

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AI443-115

Identifier Type: -

Identifier Source: org_study_id

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