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

Hepatitis C Clinical Trial

Official title:

Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104843
• Other study ID #: AI443-115
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2014
• Last updated: July 17, 2014
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

IND Number: 79,599/101,943

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Daclatasvir, Asunaprevir and BMS-791325 FDC

• BMS-791325

• Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) of Rosuvastatin		Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)	No
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin		Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)	No
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin		Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)	No
Secondary	Time of maximum observed concentration (Tmax) of Rosuvastatin		Days 1 and 15 (predose through 96 hours)	No
Secondary	Half life (T-HALF) of Rosuvastatin		Days 1 and 15 (predose through 96 hours)	No
Secondary	Apparent total body clearance (CLT/F) of Rosuvastatin		Days 1 and 15 (predose through 96 hours)	No
Secondary	Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712		Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose	No
Secondary	Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712		Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose	No
Secondary	Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712		Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose	No
Secondary	Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712		Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose	No
Secondary	Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712		Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose	No
Secondary	Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation		Days 1 through 19	Yes
Secondary	Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests		Days 1 through 19	Yes