Effect of Tepotinib on PK of CYP3A Substrate Midazolam

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tepotinib; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628339

MS200095_0030

2017-005055-92 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Midazolam (Reference Treatment)

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Tepotinib + Midazolam (Test Treatment)

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Drug: Tepotinib