First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

NCT ID: NCT01554085

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-09-30

Brief Summary

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.

Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV.

Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALS-002158

Group Type: EXPERIMENTAL

ALS-002158

Intervention Type: DRUG

ALS-002158

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

ALS-002158

ALS-002158

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject has provided written consent.
• Subject is in good health as deemed by the investigator
• Creatinine clearance of greater than 50 mL/min (Cockcroft- Gault).
• Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with CHC.
• Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with CHC, minimum weight 50 kg in both populations.
• A female is eligible to participate in this study if she is of non-childbearing potential.
• If male, subject is surgically sterile or practicing specific forms of birth control.

• Positive HCV antibody and a positive HCV RNA at screening.
• Documentation of CHC infection of greater than 6 months duration at screening.
• CHC genotype 1 infection at screening.
• HCV RNA viral load ≥ 105 and ≤ 108 IU/mL using a sensitive quantitative assay
• Liver biopsy within two years or Fibroscan evaluation within 6 months prior to screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be < 12 kPa.
• Absence of hepatocellular carcinoma as indicated by an abdominal ultrasound scan during screening.
• No prior treatment for CHC.
• Absence of history of clinical hepatic decompensation.
• Laboratory values include:

• prothrombin time < 1.5 × ULN.
• platelets > 120,000/mm3.
• albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented Gilbert's disease allowed).
• Serum ALT concentration < 5 × ULN.
• Alpha Fetoprotein (AFP) concentration ≤ ULN. If AFP is ≥ ULN, absence of a hepatic mass must be demonstrated by ultrasound within the screening period.

Exclusion Criteria

• Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
• Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.
• Abnormal screening laboratory results that are considered clinically significant by the investigator.
• Clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, including those experienced in previous trials with experimental drugs.
• Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to receiving study medication.
• Clinically significant blood loss or elective blood donation of significant volume.
• Laboratory abnormalities including:

• Thyroid Stimulating Hormone (TSH) >ULN.
• Hematocrit < 34 %.
• White blood cell counts < 3,500/mm3.
• For healthy volunteers, history of regular use of tobacco.
• The subject has a positive pre-study drug screen.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: collaborator

Alios Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QPharm

Brisbane, Queensland, Australia

CMAX

Adelaide, South Australia, Australia

Linear Clinical Research Ltd

Perth, Western Australia, Australia

Auckland Clinical Services

Auckland, , New Zealand

Christchurch Clinical Studies Trust Ltd.

Christchurch, , New Zealand

Countries

Australia; New Zealand

Other Identifiers

ALS-2158-201

Identifier Type: -

Identifier Source: org_study_id