- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554085
First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4006
- QPharm
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- CMAX
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Western Australia
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Perth, Western Australia, Australia, 6009
- Linear Clinical Research Ltd
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-
-
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Auckland, New Zealand
- Auckland Clinical Services
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Christchurch, New Zealand
- Christchurch Clinical Studies Trust Ltd.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Additional inclusion criteria for subjects with CHC genotype 1 infection:
- 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.
Laboratory values include:
- prothrombin time < 1.5 × 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 ALT concentration < 5 × ULN.
- Alpha Fetoprotein (AFP) concentration ≤ 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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placebo
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Experimental: ALS-002158
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ALS-002158
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
Time Frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
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Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCV ribonucleic acid (RNA) viral load reduction
Time Frame: Baseline to Day 31
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Baseline to Day 31
|
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Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites
Time Frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
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Maximum measured drug concentration (Cmax), time of maximum concentration (tmax), half-life (t1/2), apparent oral clearance (CL/F), area under the concentration time curve from time zero to infinity (AUC0-inf) or area under the concentration time curve from time zero to last quantifiable concentration (AUC0-last), area under the concentration time curve during the dosing interval (AUC0-tau)
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Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
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Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Time Frame: Baseline up to Month 6
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Baseline up to Month 6
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
Other Study ID Numbers
- ALS-2158-201
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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