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

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT03492437
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Dabigatran Etexilate — DRUG
    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.
  • Tepotinib — DRUG
    Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.

Study Details

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

Key Dates

Start date
May 17, 2018
Status verified
Aug 2023
Primary completion
Aug 27, 2018
Completion
Aug 27, 2018

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Dabigatran Etexilate
  • Experimental: Tepotinib + Dabigatran

Primary Outcome Measure

Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total Dabigatran [ Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours Post-dose on Day 1 and Day 8 ]

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