A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Narlaprevir; Ritonavir; Tenofovir Disoproxil Fumarate; Raltegravir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg, film-coated tablets, taken as 200 mg per os daily; 100 mg, film-coated tablets, taken as 100 mg per os daily; 300 mg, film-coated tablets, taken as 300 mg per os daily; 400 mg, film-coated tablets, taken as 400 mg per os daily
Other intervention name(s): Arlansa; Norvir; Tenofovir-TL; Viread; Isentress
Intervention MeSH terms: Ritonavir; Tenofovir; Raltegravir Potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; chronic; pharmacokinetics; HIV; coinfection; concomitant therapy