Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT03021642
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Tepotinib test (Treatment Period 1) — DRUG
    Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 1 (Day 1)
  • Tepotinib reference (Treatment Period 2) — DRUG
    Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 2 (Day 22)
  • Tepotinib reference (Treatment Period 1) — DRUG
    Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 1 (Day 1)
  • Tepotinib test (Treatment Period 2) — DRUG
    Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 2 (Day 22)

Study Details

This is a Phase I, open label, randomized, crossover trial to investigate the relative bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference, test. The reference treatment refers to the current Phase II film-coated tablet (5 \* 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III film-coated tablet (1 \* 500 mg film-coated tepotinib tablet).

Key Dates

Start date
Jan 31, 2016
Status verified
Aug 2022
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: First Tepotinib Test, Then Tepotinib Reference
  • Experimental: First Tepotinib Reference, Then Tepotinib Test

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) at Concentration at or Above Lower Limit of Quantitation (LLOQ) of Tepotinib [ Time Frame: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2 ]

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