NCT03537404

A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Narlaprevir	100 mg, film-coated tablets, taken as 200 mg per os daily
DRUG	Ritonavir	100 mg, film-coated tablets, taken as 100 mg per os daily
DRUG	Tenofovir Disoproxil Fumarate	300 mg, film-coated tablets, taken as 300 mg per os daily
DRUG	Raltegravir	400 mg, film-coated tablets, taken as 400 mg per os daily

Timeline

• Start date: 2017-04-24
• Primary completion: 2017-06-24
• Completion: 2017-06-30
• First posted: 2018-05-25
• Last updated: 2019-02-19
• Results posted: 2019-02-19

Locations

1 site across 1 country: Russia