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.

Phase 1

• Conditions: This current study is being conducted in healthy volunteers to learn about the way this drug behaves in the body when it is given at different doses. The study will also be conducted in patients with Hepatitis C genotype 1.; Infection - Other infectious diseases

• Registration Number: ACTRN12614000304639
• Lead Sponsor: Achillion Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified