Effect of Tepotinib on PK of CYP3A Substrate Midazolam

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT03628339
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Midazolam — DRUG
    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.
  • Tepotinib — DRUG
    Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.

Study Details

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.

Key Dates

Start date
Aug 20, 2018
Status verified
Sep 2022
Primary completion
Oct 25, 2018
Completion
Oct 30, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Midazolam (Reference Treatment)
    Participants received single oral dose of 7.5 milligrams (mg) midazolam tablet on Day 1 of treatment period 1. The washout period between midazolam administrations in Period 1 and Period 2 was 12 days.
  • Experimental: Tepotinib + Midazolam (Test Treatment)
    All participants who received 7.5 mg midazolam tablet in treatment period 1 received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 along with 7.5 mg midazolam tablet on Day 11 in treatment period 2.

Primary Outcome Measure

Area Under Plasma Concentration-time Curve From Time Zero to Last Sampling Time (Tlast) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Midazolam [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 43 hours post-dose on Day 1 of period 1 and Day 11 of Period 2 ]

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