CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Narlaprevir +3 moredrug
Likely dose
Narlaprevir 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537404
NCT03537404Phase 1Completed
CompareCT.gov

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

R-Pharm·interventional·Posted May 25, 2018·Updated Feb 19, 2019

In Brief

A Phase 1 clinical trial evaluating Narlaprevir, Ritonavir, and 2 other interventions for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
CollaboratorsAlmedis

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartApr 24, 2017
Primary CompletionJun 24, 2017
Study CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.1 years ago

Interventions

Narlaprevirdrug

100 mg, film-coated tablets, taken as 200 mg per os daily

Ritonavirdrug

100 mg, film-coated tablets, taken as 100 mg per os daily

Tenofovir Disoproxil Fumaratedrug

300 mg, film-coated tablets, taken as 300 mg per os daily

Raltegravirdrug

400 mg, film-coated tablets, taken as 400 mg per os daily