At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 20 enrolled
Drug / intervention
Dabigatran Etexilate Mesylate +1 moredrug
Likely dose
Dabigatran Etexilate Mesylate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Fixed Sequence Drug Interaction Study to Evaluate the Potential Intestinal Inhibitory Effect of Quizartinib on the Pharmacokinetics of a Pgp Substrate Dabigatran Etexilate in Healthy Subjects
In Brief
A Early Phase 1 clinical trial evaluating Dabigatran Etexilate Mesylate and Quizartinib for Healthy Subjects and 3 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartAug 2020
Primary CompletionOct 2020
TodayJul 2026
First PostedJul 7, 2020
Enrollment StartAug 28, 2020
Primary CompletionOct 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.0 years ago
Interventions
Dabigatran Etexilate Mesylatedrug
Single oral 150 mg capsule dose
Quizartinibdrug
Single oral 60 mg dose of quizartinib administered as two 30 mg tablets (26.5 mg free base per tablet)