MedTrace Logo

Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet

NCT03817619 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-10-19

No results posted yet for this study

Summary

Elbasvir/grazoprevir (Zepatier®) is a once-daily tablet for the treatment of chronic hepatitis C virus (HCV) GT1a, 1b or 4 infection containing the NS5A inhibitor elbasvir (ELB) 50 mg and the NS3/4A protease inhibitor grazoprevir (GZR) 100 mg.

For patients with swallowing difficulties, administration of whole tablets can be problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. Therefore it is useful to know whether it is possible to administer ELB/GZR through a different route, like a feeding tube.

In daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in noncompliance, interruption or discontinuation of expensive HCV therapy. However, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restarting).

Currently, patients and healthcare professionals are crushing tablets without information about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs.

It is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma concentrations of ELB and/or GZR potentially reduces the therapeutic effect of the drugs. Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher Cmax and/or AUC occurs there might be an increased risk of toxicity.

As a result, crushing the drug is a contra-indication based on the available data. Therefore this study will be conducted to investigate whether a crushed ELB/GZR tablet is bioequivalent to ELB/GZR as a whole tablet.

Conditions

  • Hepatitis C
  • Deglutition Disorders

Interventions

DRUG

Zepatier whole tablet

Single-dose ELB/GZR as a whole tablet in a fasted state.

DRUG

Zepatier crushed tablet

Single-dose crushed ELB/GZR in a fasted state.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT03817619 on ClinicalTrials.gov