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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Alios Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT01590407
First received: March 12, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • HCV ribonucleic acid (RNA) viral load reduction [ Time Frame: Baseline to Day 31 ] [ Designated as safety issue: No ]
  • Amino Acid Changes in HCV polymerase NS5b [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
    Comparison of baseline with on-treatment or post-treatment Hepatitis C virus (HCV) NS5B RNA sequence


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALS-002200 Drug: ALS-002200
ALS-002200
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590407

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

No publications provided

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT01590407     History of Changes
Other Study ID Numbers: ALS-2200-101
Study First Received: March 12, 2012
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014