Clinical trial NCT00546715: A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
Official title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-790052 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection


Eligibility criteria: Key Inclusion Criteria:

* Chronically infected with hepatitis C virus genotype 1
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus
* Hepatitis C virus RNA viral load of ≥ 10\*5\* IU/mL
* BMI 18 to 35 kg/m²

Key Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hepatitis C virus infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
timeFrame: Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings
timeFrame: Day 1 up to Day 7 or Discharge
measure: Number of Participants With Marked Abnormalities in Laboratory Findings
timeFrame: Day 1 up to Day 7
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
measure: Plasma Half-life (T-half)
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
measure: Apparent Total Body Clearance (CLT/F)
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1
measure: Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
timeFrame: Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1
measure: Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline
timeFrame: Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1
measure: Change From Baseline in Heart Rate to Day 7 or Discharge
timeFrame: Baseline (Day 1), Day 7 or Discharge
measure: Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge
timeFrame: Baseline (Day 1), Day 7 or Discharge
measure: Change From Baseline in Blood Pressure to Day 7 or Discharge
timeFrame: Baseline (Day 1), Day 7 or Discharge
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Baltimore
country: United States
facility: Parexel International Corporation
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hamilton
country: United States
facility: Bristol-Myers Squibb Clinical Pharmacology Unit
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charlottesville
country: United States
facility: University Of Virginia Digestive Health Center Of Excellence
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: