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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2018-08-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Tolerability，Safety，PK/PD Study of rhTPO in the Patients With Liver Function Impairment

NCT03673215

Liver Cirrhosis

UNKNOWN EARLY_PHASE1

A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia

NCT06721013

Immune Thrombocytopenia (ITP)

RECRUITING PHASE1/PHASE2

A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults

NCT07083739

Primary Immune Thrombocytopenia

NOT_YET_RECRUITING PHASE2

Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

NCT03492515

Immune Thrombocytopenia

UNKNOWN PHASE3

Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

NCT03554759

Thrombocytopenia

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dabigatran Etexilate

Group Type EXPERIMENTAL

Dabigatran Etexilate

Intervention Type 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 + Dabigatran

Group Type EXPERIMENTAL

Dabigatran Etexilate

Intervention Type 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

Intervention Type DRUG

Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Tepotinib

Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 to use highly effective method of contraception
* Participant must have given written informed consent before any study-related activities
* All values for hematology, coagulation, and biochemistry tests of blood and urinalysis are within the normal range. Minor (solitary) non-clinically relevant deviation(s) are allowed as judged by the Investigator

Exclusion Criteria

* Participation in a clinical study within 60 days prior to first drug administration
* Whole blood donation or loss of \> 450 milliliter (mL) within 60 days prior to first drug administration
* Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation
* Supine systolic blood pressure (SBP) greater than (\>) 140 millimeter of mercury (mmHg) or less than (\<) 90 mmHg, diastolic blood pressure (DBP) \> 90 or \< 50 mmHg, and pulse rate \> 90 or \<50 beats per minute (bpm) at Screening and at admission on Day-1.
* 12-Lead electrocardiograms (ECG) showing a corrected QT interval per Fridericia's formula (QTcF) \> 450 milliseconds (ms), PR \> 215 ms, or QRS \> 120 ms (at Screening)
* Creatinine clearance estimated glomerular filtration rate (eGFR) \< 90 milliliter per minute (mL/min) (at Screening)
* Participants with gall bladder removal or other relevant surgery of gastrointestinal tract
* History of any malignancy
* History of epilepsy
* Ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or excipients
* Participants who in the Investigator's judgment were perceived as having an increased risk of bleeding
* Positive screen for alcohol or drugs of abuse (at Screening and Day -1)
* Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), and human immunodeficiency virus 1 and 2 antibodies (HIV1/HIV2 antibodies) (at Screening)
* Excessive consumption of xanthine-containing food or beverages before study drug administration until collection of last pharmacokinetic (PK) sample in each period (at Screening and Day -1)
* Receipt of any prescription or nonprescription medication within 14 days or 5 half-lives, before study drug administration
* Smoker or former smoker who stopped smoking less than 6 months before the time of the Screening Visit
* Intake of grapefruit, Seville orange, cranberry or juices of these 3 fruits, or St. John's Wort, from 14 days prior to Day -1
* Inability to communicate or cooperate with the Investigator
* Other factors, which in the opinion of the Investigator may interfere with study conduct (at Screening and Day -1 of first Period only)
* Legal incapacity or limited legal capacity
* Participants kept in detention

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes