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

This study has been completed.
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Alios Biopharma Inc. Identifier:
First received: March 12, 2012
Last updated: January 22, 2015
Last verified: January 2015

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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: ALS-002200
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002200 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

Resource links provided by NLM:

Further study details as provided by Alios Biopharma Inc.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to Day 31 ]
    data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results

Secondary Outcome Measures:
  • Cmax [ Time Frame: pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose ]
  • AUC [ Time Frame: pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose ]
  • HCV ribonucleic acid (RNA) viral load reduction [ Time Frame: Baseline to Day 31 ]
  • Amino Acid Changes in HCV polymerase NS5b [ Time Frame: Baseline up to Month 6 ]
    Comparison of baseline with on-treatment or post-treatment Hepatitis C virus (HCV) NS5B RNA sequence

Enrollment: 71
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALS-002200 Drug: ALS-002200
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Additional inclusion criteria for subjects with CHC genotype 1 infection:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01590407

Rennes, Brittany, France
Paris, France
Moldova, Republic of
Chisinau, Moldova, Republic of
Bucharest, Romania
Sponsors and Collaborators
Alios Biopharma Inc.
Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Alios Biopharma Inc. Identifier: NCT01590407     History of Changes
Other Study ID Numbers: ALS-2200-101
Study First Received: March 12, 2012
Last Updated: January 22, 2015

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections processed this record on April 26, 2017