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

NCT03537404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-19

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Almedis

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2017-06-24
Completion
2017-06-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537404 on ClinicalTrials.gov