Chronic Hepatitits C Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-part Study of Orally Administered JNJ-54257099 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1) and Food-effect (Part 2) in Healthy Subjects, and Multiple Doses in Subjects With Chronic Hepatitis C Infection (Part 3)
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study
in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be
assessed in healthy adult subjects and in adult subjects with CHC infection.
Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of
AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be
randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2
assigned to placebo), in a fasted state.
The planned dose-escalation scheme may be changed based on the emerging PK and safety data.
Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses
at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK)
profile, and the presence of an acceptable safety profile.
Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part
1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the
same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14
days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be
selected, however this depends on the evaluation of available PK and safety data from Part 1
of the study.
Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be
evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC
genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7
consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed
state. The treatment is anticipated to be administered in a once daily dose regimen or a
twice daily dose regimen. The dose and dose regimen to be administered will be determined by
the Sponsor depending on the PK and safety outcomes of previous cohorts.
n/a