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A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

NCT02945020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate mesylate

Participants will receive dabigatran etexilate mesylate 75 mg, orally.

DRUG

Odalasvir (ODV)

Participants will receive ODV 25 mg, orally.

DRUG

Simeprevir (SMV)

Participants will receive SMV 75 mg, orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2017-01-09
Completion
2017-01-20

Countries

  • United States

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 NCT02945020 on ClinicalTrials.gov