Phase 2 N=30 Randomized Double-blind Treatment

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT00663208 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants — -2.13; -3.31; -2.91; -2.58 log10 IU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Daclatasvir (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants	-2.13; -3.31; -2.91; -2.58; -3.03; -3.56	—
SECONDARY Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance	-2.13; -3.31; -2.91; -2.58; -3.03; -3.56	—
SECONDARY Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance	0.02; -0.00; -0.21; -0.43; -0.35; 0.04	—
SECONDARY Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance	-2.16; -3.29; -3.04; -3.85; -3.82; -3.14	—
SECONDARY Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance	-1.89; -2.32; -1.68; -1.34; -3.55; -1.35	—
SECONDARY Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance	4.50; 5.25; 3.50; 3.33; 10.33; 7.67	—
SECONDARY Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance	-2.81; -3.63; -3.31; -4.03; -4.88; -3.62	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14	15.731; 159.665; 483.365; 1409.202; 563.569; 1960.732	—
SECONDARY Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14	111.8; 1113.6; 3528.6; 10691.5; 3307.2; 15136.1	—
SECONDARY Plasma Half-life (T-half) of Daclatasvir at Day 14	11.68; 14.31; 12.99; 12.81; 13.04; 15.19	—
SECONDARY Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14	181.118; 125.119; 113.861; 66.133; 92.054; 94.736	—
SECONDARY Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14	4.659; 46.401; 147.024; 445.478; 275.596; 630.673	—
SECONDARY Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14	0.823; 1.196; 1.245; 1.414; 1.642; 1.162	—
SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14	2.000; 1.000; 1.000; 1.500; 2.500; 1.500	—
SECONDARY Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance	-0.61; -0.61; -0.63; -0.51; -0.50; -0.59	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities in Hematology	0; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes	0; 1; 0; 1; 2; 2	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose	0; 1; 0; 0; 1; 0	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities in Urinalysis	1; 1; 0; 1; 0; 0	—
SECONDARY Number of Participants With Clinically Relevant Change From Baseline in Vital Signs	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters	0; 0; 0; 0; 0; 0	—

Summary

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Eligibility Criteria

Inclusion Criteria

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

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
HIV and/or HBV positive
Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00663208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.