CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Tepotinib test (Treatment Period 1) +3 moredrug
Likely dose
Tepotinib test (Treatment Period 1) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03021642
NCT03021642Phase 1Completed
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A Phase I, Open-label, Randomized, Cross-over Trial to Investigate the Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers

Merck KGaA, Darmstadt, Germany·interventional·Posted Jan 16, 2017·Updated Aug 24, 2022

In Brief

A Phase 1 clinical trial evaluating Tepotinib test (Treatment Period 1), Tepotinib reference (Treatment Period 2), and 2 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 16, 2017
Enrollment StartJan 31, 2016
Primary CompletionMar 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago

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)