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Dabigatran Etexilate

Phase 1

Undisclosed | Small molecule | Other |Merck KGaA|Trials Updated: Aug 7, 2023

Dabigatran Etexilate development status

Highest phase Phase 1
Registered trials 17 across 12 sponsors since Jun 2011

Dabigatran Etexilate target and mechanism

Molecular targetF2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Dabigatran Etexilate clinical trials

Dabigatran Etexilate · 1 trial · 1 indication

Phase 1 1
NCT03492437Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran EtexilateHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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

AUC0-t was calculated according to the mixed log linear trapezoidal rule.

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Total Dabigatran
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

AUC0-inf was calculated as AUC0-t plus (+) AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastpred/Lambda z, where Clastpred is the predicted plasma concentration at the last sampling time point, calculated from the log-linear regression line for Lambda z determination at which the measured plasma concentration is at or above Lower limit of quantification (LLOQ).

Maximum Observed Plasma Concentration (Cmax) of Total Dabigatran
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

Cmax was obtained directly from the concentration versus time curve.

Secondary Endpoints

Time to Reach Maximum Plasma Concentration (Tmax) of Total Dabigatran
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
Elimination Half Life (t1/2) of Total Dabigatran
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
Apparent Clearance (CL/f) of Total Dabigatran
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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Study Design & Arms

AllocationNA
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Dabigatran EtexilateEXPERIMENTAL -
Tepotinib + DabigatranEXPERIMENTAL -

Interventions

NameTypeDescription
Dabigatran EtexilateDRUGParticipants 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.
TepotinibDRUGParticipants received single oral dose of Tepotinib for 8 days in Treatment period 2.
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Eligibility Criteria

Age Range18 Years to 44 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants of non-child bearing potential * Body weight between 50 to 100 kilogram (kg) * Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) * A male participant must agree to use and to have his female partner of childbearing potential t...

Countries:Germany
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