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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
ALS-002158
placebo
QPharm
Brisbane, Queensland, Australia
CMAX
Adelaide, South Australia, Australia
Linear Clinical Research Ltd
Perth, Western Australia, Australia
Auckland Clinical Services
Auckland, New Zealand
Christchurch Clinical Studies Trust Ltd.
Christchurch, New Zealand
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
Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites
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)
Time frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
HCV ribonucleic acid (RNA) viral load reduction
Time frame: Baseline to Day 31
Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Time frame: Baseline up to Month 6
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