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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC; Drug: BMS-791325; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02104843

AI443-115

Details and patient eligibility

About

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

Full description

IND Number: 79,599/101,943

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

18 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: BMS-791325

Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC