NCT04459585

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will evaluate the potential intestinal inhibitory effect of quizartinib on the pharmacokinetics of a Pgp substrate dabigatran etexilate in healthy participants. The hypothesis for this clinical study is that quizartinib, as a P-gp inhibitor, may increase the systemic exposure (measured by area under the concentration-time curve \[AUC\] and maximum concentration \[Cmax\]) of P-gp substrates that may be sensitive to intestinal P-gp inhibition.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-08-28
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2020-07-07
• Last updated: 2021-07-09
• Results posted: 2021-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study