Clinical trial NCT02104843: Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin
Official title: Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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

Detailed description: IND Number: 79,599/101,943

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

Eligibility 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

Primary outcomes:
measure: Maximum observed concentration (Cmax) of Rosuvastatin
timeFrame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin
timeFrame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin
timeFrame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Secondary outcomes:
measure: Time of maximum observed concentration (Tmax) of Rosuvastatin
timeFrame: Days 1 and 15 (predose through 96 hours)
measure: Half life (T-HALF) of Rosuvastatin
timeFrame: Days 1 and 15 (predose through 96 hours)
measure: Apparent total body clearance (CLT/F) of Rosuvastatin
timeFrame: Days 1 and 15 (predose through 96 hours)
measure: Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
timeFrame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
measure: Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
timeFrame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
measure: Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
timeFrame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
measure: Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
timeFrame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
measure: Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712
timeFrame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose
measure: Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation
timeFrame: Days 1 through 19
measure: Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
timeFrame: Days 1 through 19
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: