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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

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: NCT01590407
Recruitment Status : Completed
First Posted : May 3, 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-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 or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: ALS-002200 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 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-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
Actual Study Start Date : December 31, 2011
Actual Primary Completion Date : February 28, 2013
Actual Study Completion Date : February 28, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ALS-002200 Drug: ALS-002200

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. HCV ribonucleic acid (RNA) viral load reduction [ Time Frame: Baseline to Day 31 ]
  4. 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

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.

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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.
  • 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

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): NCT01590407

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

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Responsible Party: Alios Biopharma Inc. Identifier: NCT01590407    
Other Study ID Numbers: ALS-2200-101
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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