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

NCT01590407 | Completed Phase 1

• 1 other identifier: ALS-2200-101
• Study Type: interventional
• Target: 71
• Locations: 3 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results

  up to Day 31

Secondary Outcomes (4)

• Cmax

  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

  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

  Baseline to Day 31

• Amino Acid Changes in HCV polymerase NS5b

  Baseline up to Month 6

Study Arms (2)

ALS-002200

EXPERIMENTAL

Drug: ALS-002200

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALS-002200 DRUG

ALS-002200

ALS-002200

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alios Biopharma Inc.: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (4)

Biotrial

Rennes, Brittany Region, France

Location

Biotrial

Paris, France

Location

Arensia

Chisinau, Moldova

Location

Arensia

Bucharest, Romania

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: May 3, 2012
• Study Start: December 31, 2011
• Primary Completion: February 28, 2013
• Study Completion: February 28, 2013
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

FR (2); RO (1); MO (1)