At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Midazolam 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1, Open-label, Single Sequence, Two-Period Crossover Trial to Evaluate the Effect of Tepotinib on CYP3A by Investigating the PK of the CYP3A Substrate Midazolam in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Midazolam and Tepotinib for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main metabolite 1-hydroxymidazolam in healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartAug 2018
Primary CompletionOct 2018
Study CompletionOct 2018
TodayJul 2026
First PostedAug 14, 2018
Enrollment StartAug 20, 2018
Primary CompletionOct 25, 2018
Study CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.9 years ago
Interventions
Midazolamdrug
Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2.
Tepotinibdrug
Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.