This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Samatasvir 150 mg oral tablets (50mg x 3), single dose
40 mg delayed-release oral capsules, once daily
100 mg oral tablets, once daily
Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration
Time frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
Pharmacokinetic parameter: AUC from time zero to infinity
Time frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
Pharmacokinetic parameter: Maximum observed drug concentration (Cmax)
Time frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
Percentage of participants who experienced at least one serious adverse event
Time frame: Up to 17 days
Percentage of participants who experienced at least one adverse event
Time frame: Up to 17 days
Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality
Time frame: Up to 17 days
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