To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.
Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
Placebo
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
San Antonio, Texas, United States
HCV viral load
Viral load samples will be taken at Day 3.
Time frame: Day 3
Number of participants with adverse events as a measure of safety
Time frame: 2 weeks
Total BZF961 concentration in plasma
Time frame: Day 4
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