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

NCT01554085 | Terminated Phase 1

• 1 other identifier: ALS-2158-201
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 5

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results

  Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31

Secondary Outcomes (3)

• Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites

  Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31

• HCV ribonucleic acid (RNA) viral load reduction

  Baseline to Day 31

• Sequence analysis of the Hepatitis C virus (HCV) NS5B region

  Baseline up to Month 6

Study Arms (2)

ALS-002158

EXPERIMENTAL

Drug: ALS-002158

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALS-002158 DRUG

ALS-002158

ALS-002158

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.
• 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 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.

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.
• 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.

Sponsors & Collaborators

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

Study Sites (5)

QPharm

Brisbane, Queensland, 4006, Australia

Location

CMAX

Adelaide, South Australia, 5000, Australia

Location

Linear Clinical Research Ltd

Perth, Western Australia, 6009, Australia

Location

Auckland Clinical Services

Auckland, New Zealand

Location

Christchurch Clinical Studies Trust Ltd.

Christchurch, New Zealand

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: March 14, 2012
• Study Start: December 31, 2011
• Primary Completion: September 30, 2012
• Study Completion: September 30, 2012
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

NZ (2); AU (3)