Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554085
Recruitment Status : Terminated (ALS-2158 showed insufficient antiviral activity to warrant proceeding with further clinical development.)
First Posted : March 14, 2012
Last Update Posted : October 31, 2017
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Alios Biopharma Inc.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: ALS-002158 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection
Actual Study Start Date : December 31, 2011
Actual Primary Completion Date : September 30, 2012
Actual Study Completion Date : September 30, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ALS-002158 Drug: ALS-002158

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results [ Time Frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31 ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites [ Time Frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31 ]
    Maximum measured drug concentration (Cmax), time of maximum concentration (tmax), half-life (t1/2), apparent oral clearance (CL/F), area under the concentration time curve from time zero to infinity (AUC0-inf) or area under the concentration time curve from time zero to last quantifiable concentration (AUC0-last), area under the concentration time curve during the dosing interval (AUC0-tau)

  2. HCV ribonucleic acid (RNA) viral load reduction [ Time Frame: Baseline to Day 31 ]
  3. Sequence analysis of the Hepatitis C virus (HCV) NS5B region [ Time Frame: Baseline up to Month 6 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Additional inclusion criteria for subjects with CHC genotype 1 infection:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554085

Layout table for location information
Australia, Queensland
Brisbane, Queensland, Australia, 4006
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Linear Clinical Research Ltd
Perth, Western Australia, Australia, 6009
New Zealand
Auckland Clinical Services
Auckland, New Zealand
Christchurch Clinical Studies Trust Ltd.
Christchurch, New Zealand
Sponsors and Collaborators
Alios Biopharma Inc.
Vertex Pharmaceuticals Incorporated

Layout table for additonal information
Responsible Party: Alios Biopharma Inc. Identifier: NCT01554085     History of Changes
Other Study ID Numbers: ALS-2158-201
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic