Phase 2
Completed N=18
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00546715 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died — 0; 0; 0; 0 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Marked Abnormalities in Laboratory Findings |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24) |
15.7; 177.6; 2416.5; 2.7; 32.2; 706.7 | — |
| SECONDARY 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 |
126.8; 1413.9; 28239.1; 129.1; 1431.1; 29256.1 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) |
1; 1; 1.5 | — |
| SECONDARY Plasma Half-life (T-half) |
9.7; 12.1; 14.0 | — |
| SECONDARY Apparent Total Body Clearance (CLT/F) |
129.1; 116.5; 57.0 | — |
| SECONDARY Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
2.12; 3.24; 3.28; -0.12; 2.44; 3.12 | — |
| SECONDARY Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline |
16.4; 43.2; 105.60; 144 | — |
| SECONDARY Change From Baseline in Heart Rate to Day 7 or Discharge |
7.3; 7.6; 1.6; 14 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge |
-27.5; -18.6; -1.2; -36; -13.3; -5.6 | — |
| SECONDARY Change From Baseline in Blood Pressure to Day 7 or Discharge |
9.6; 4.3; 3.7; 1; 14; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00546715). 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. Informational only — not medical advice.