Healthy Clinical Trial
Official title:
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and Narlaprevir, Ritonavir and Raltegravir (part 2) are administered in combination to healthy volunteers.
The current study includes 2 parts, as the following drugs may be used concomitantly to treat
hepatitis C virus (HCV)/HIV coinfection:
- Part 1 of the study is being conducted to evaluate the pharmacokinetic effect of
coadministration of narlaprevir with ritonavir and tenofovir disoproxil fumarate.
- Part 2 of the study is being conducted to evaluate the pharmacokinetic effect of
coadministration of narlaprevir/ritonavir and raltegravir.
Each part of the study is designed as a randomized 3-period crossover study and will assess
if there is any effect of tenofovir disoproxil fumarate or raltegravir on the
pharmacokinetics of narlaprevir and vice versa.
Subjects will be screened within 28 days before dosing in this multi-part study. All subjects
eligible for protocol criteria will be randomized 1:1:1 to receive one of the following
treatment sequences: A/B/C, or B/C/A, or C/A/B. Every subject will receive only one treatment
(A or B or C) in one Period. Subjects will be confined to the study center throughout
treatment in each period. Following completion of study procedures for each treatment period,
subjects will be released from the clinic. After a 7-14 (maximum) days interval between
dosing, subjects will return to start hospitalization for the next treatment period. Subjects
will be discharged from the study upon completion of all study related procedures in Period
3. Phone call will be conducted after 5-7 days of follow-up period to assess safety data.
This drug interaction study is designed to investigate pharmacokinetic drug-drug interactions
between Narlaprevir coadministered with Ritonavir and antiretroviral drugs (Tenofovir
disoproxil fumarate and Raltegravir) for labeling and clinical dosing guidance purposes.
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