Evaluation of IDX375 in healthy and hepatitis C-infected subjects

Completed

• Conditions: Genotype 1 chronic hepatitis C virus; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN80501908
• Lead Sponsor: Idenix Pharmaceuticals, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified