NCT03492437

Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate

Phase I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	Participants received single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.
DRUG	Tepotinib	Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.

Timeline

• Start date: 2018-05-17
• Primary completion: 2018-08-27
• Completion: 2018-08-27
• First posted: 2018-04-10
• Last updated: 2023-08-07
• Results posted: 2023-08-07

Locations

1 site across 1 country: Germany