This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
42
Unnamed facility
Montpellier, France
Unnamed facility
Strasbourg, France
Unnamed facility
Leiden, Netherlands
Unnamed facility
Chorzów, Poland
Unnamed facility
Warsaw, Poland
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
Time frame: up to 17 days
Parts A + B: Safety: Incidence of adverse events
Time frame: up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
Time frame: up to 24 days
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
Time frame: up to 17 days
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Unnamed facility
Wroclaw, Poland