Phase 1
N=18
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04204902 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Tepotinib — 15348; 16523 Hours*nanogram per milliliter (hr*ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tepotinib 100 mg (Drug); Tepotinib 250 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Tepotinib |
15348; 16523 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib |
15958; 17201 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Tepotinib |
252; 240 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib |
12.0; 20.1 | — |
| SECONDARY Terminal Half-Life (t1/2) of Tepotinib |
33.1; 32.1 | — |
| SECONDARY Apparent Volume of Distribution During Terminal Phase (Vz/f) for Tepotinib |
1347; 1211 | — |
| SECONDARY Apparent Total Body Clearance (CL/f) of Tepotinib |
28.2; 26.2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation |
7; 6; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters, 12-lead Electrocardiogram (ECG) Findings and Vital Signs |
1; 0; 0; 0; 0; 0 | — |
Summary
This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under fasted condition.
Eligibility Criteria
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)
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Participation in a clinical study within 60 days prior to first drug administration
- Whole blood donation or loss of greater than 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
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT04204902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.