A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Oral ACH-0143422 after Single and Multiple-ascending Doses in Health Volunteers and Subjects With Chronic Hepatitis C Virus Genotype 1 Infection.

Achillion Pharmaceuticals, Inc0 个研究点目标入组 157 人开始时间: 2014年3月21日最近更新: 2020年1月13日

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•Inclusion criteria for Healthy Volunteers:
•1. Between 18 and 55 years old
•2.No clinically relevant health abnormalities
•3.Agree to use effective contraception (defined in the protocol)4. HCV GT-1 (Groups 9, 10, 11, 12A and 12B), HCV GT-3 (Group 12C) and HCV GT-2 (Group 12D) including all subtypes, mixed subtypes or subtypes undetermined
•5.Body mass index of 18 to 30 kg/m2 with a minimum body weight of 50 kg
•Inclusion criteria for patients:
•1. Aged 18 to less than 70 years old
•2. Treatment naive subjects with chronic HCV infection
•3. BMI of 18 to 36 kg/m2 with a minimum body weight of 50 kg
•4.HCV genotype 1 (including 1a, 1b, or mixed subtypes of genotype 1)
•5.HCV RNA greater or equal to 10,000 IU/mL at screening

•Exclusion criteria for healthy volunteers:
•1. History of any clinically relevant illness or clinically significant laboratory abnormalities or ECG (defined in the protocol)
•2. Pregnant or nursing females
•3. Febrile illness within 7 days of first dose of study drug
•4. Current Smoker
•5. Positive urine drug screen at day 0-1
•6. Regular alcohol consumption
•7. Any condition possibly affecting drug absorption (e.g., gastrectomy)
•8. Use of prescription drugs, non-prescription drugs, dietary supplements, herbal supplements, and hormonal therapy/replacement, or ingestion of foods which are CYP3A4 substrates, inducers and inhibitors within 14 prior to the first dose of study medication unless approved by the Investigator and Sponsor
•Exclusion criteria for patients:
•As above and also including:
•1. History of participation in a clinical trial with a polymerase inhibitor or previous treatment with a polymerase inhibitor, where at least one dose of the polymerase inhibitor was consumed. Subjects who were dosed with placebo on a clinical trial may be enrolled in this study
•2. Co-infection with HIV-1, HIV-2 or HBV
•3. Subjects with a history of liver disease

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