First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

NCT ID: NCT01590407

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-02-28

Brief Summary

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 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-002200

Group Type: EXPERIMENTAL

ALS-002200

Intervention Type: DRUG

ALS-002200

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

ALS-002200

ALS-002200

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject has provided written consent.
• In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
• 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 for greater than 6 months 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 ultrasound scan conducted during screening
• No prior treatment for CHC
• Absence of history of clinical hepatic decompensation.
• Laboratory values include:

• Prothrombin time < 1.5x 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 alanine aminotransferase (ALT) concentration < 5 x ULN
• Alpha Fetoprotein (AFP) concentrations ≤ 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.
• 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 study medication.
• Clinically significant blood loss or elective blood donation of significant volume.
• For healthy subjects, history of regular use of tobacco.
• The subject has a positive pre-study drug screen.
• Laboratory abnormalities including:

• Thyroid Stimulating Hormone (TSH) > ULN
• Hematocrit < 34 %
• White blood cell counts < 3,500/mm3

• 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

Biotrial

Rennes, Brittany Region, France

Biotrial

Paris, , France

Arensia

Chisinau, , Moldova

Arensia

Bucharest, , Romania

Countries

France; Moldova; Romania

Other Identifiers

ALS-2200-101

Identifier Type: -

Identifier Source: org_study_id