Genotype 1 chronic hepatitis C virus Infections and Infestations Chronic viral hepatitis
Conditions
Interventions
1. Dose escalation in healthy subjects - 8 subjects per dosing cohort, randomised 6:2 (active:placebo):
1.1. 200 mg IDX375 (or placebo) x 1 day
1.2. 400 mg IDX375 (or placebo) on days 1 and 8
1.3. 300
Sponsors
Idenix Pharmaceuticals, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants: 1. Aged 18 - 65 years 2. Body mass index (BMI) 18 - 35 kg/m^2 3. Must agree to use an acceptable double-barrier method of birth control 4. Male subject must agree not to donate sperm for 90 days after the last dose of study drug 5. Subject has provided written informed consent to participate in the study Specific to healthy subjects: 6. Subject must be male 7. Subject must be a non-smoker Specific to HCV-infected subjects: 8. Female subjects must be of non-childbearing potential 9. Documented clinical history compatible with chronic hepatitis C 10. Plasma HCV ribonucleic acid (RNA) greater than or equal to 5 log10 IU/mL at screening 11. HCV genotype 1 12. HCV treatment-naive
Exclusion criteria
Exclusion criteria: All participants: 1. Co-infected with hepatitis B virus and/or human immunodeficiency virus (HIV) 2. Donated blood or had significant blood loss 60 days prior to dosing 3. Use of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the Investigator 4. Use of other investigational drugs within 60 days of dosing, or plans to enrol in another clinical trial of an investigational agent while participating in the present study 5. Subject with known allergy to the study medication or any of its components 6. Clinically significant laboratory or electrocardiogram (ECG) abnormalities 7. Any clinically significant medical condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results Specific to healthy subjects: 8. Concomitant use of prescription medications or systemic over-the-counter (OTC) medications. A washout period of at least 5 half-lives must be observed prior to study drug dosing, if the Investigator feels that the medication can be safely discontinued for the duration of the study. 9. Positive screen for anti-HCV antibody Specific to HCV-infected subjects: 10. Subject is pregnant or breastfeeding 11. History or signs of decompensated liver disease: Child-Pugh class B or C, ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency 12. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse events, physical examination, vital signs, electrocardiograms (ECGs), standard safety laboratory tests 2. Change in plasma HCV RNA, emergence of resistance mutations Measured daily during research unit confinement up to 14 days maximum, with weekly visits for follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of IDX375. Measured daily during research unit confinement up to 14 days maximum, with weekly visits for follow-up. | — |
Countries
Belgium, Moldova
Outcome results
None listed