A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 4/21/2016 |
| Start Date: | November 2007 |
| End Date: | May 2008 |
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
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
single oral doses of daclatasvir in subjects with chronic hepatitis C infection
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
We found this trial at
7
sites
Click here to add this to my saved trials
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Click here to add this to my saved trials