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

Bristol-Myers Squibb18 enrolled

Overview

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

IND Number: 79,599/101,943 Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

Daclatasvir, Asunaprevir and BMS-791325 FDCDRUG

BMS-791325DRUG

RosuvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax) of Rosuvastatin

Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin

Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin

Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Secondary Outcomes

Time of maximum observed concentration (Tmax) of Rosuvastatin

Time frame: Days 1 and 15 (predose through 96 hours)

Half life (T-HALF) of Rosuvastatin

Time frame: Days 1 and 15 (predose through 96 hours)

Apparent total body clearance (CLT/F) of Rosuvastatin

Time frame: Days 1 and 15 (predose through 96 hours)

Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

Data from ClinicalTrials.gov

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