MedTrace Logo

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

NCT04459585 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-09

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.

Conditions

  • Healthy Subjects
  • Drug-drug Interaction
  • Pharmacokinetics
  • Quizartinib

Interventions

DRUG

Dabigatran Etexilate Mesylate

Single oral 150 mg capsule dose

DRUG

Quizartinib

Single oral 60 mg dose of quizartinib administered as two 30 mg tablets (26.5 mg free base per tablet)

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2020-10-20
Completion
2020-10-20
FDA Drug
Yes

Countries

  • United States

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 NCT04459585 on ClinicalTrials.gov