MedTrace Logo

Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)

NCT01470690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-01

No results posted yet for this study

Summary

The objective of this study is to determine the effect of multiple dose omeprazole on the pharmacokinetics of boceprevir and vice versa.

Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole will be evaluated.

Conditions

  • HCV Infections
  • Gastric Acid-related Disorders

Interventions

DRUG

boceprevir

Boceprevir 800 mg TID for 4 consecutive days + a single dose of 800 mg on Day 5

DRUG

Omeprazole

Omeprazole 40 mg QD for 5 consecutive days

Sponsors & Collaborators

Principal Investigators

  • David Burger, Prof PharmD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT01470690 on ClinicalTrials.gov