Clinical trial

Phase I, Open-label, Three-Period Crossover Study to Investigate the Effect of a Proton Pump Inhibitor (Omeprazole) on the PK of Tepotinib in Healthy Subjects

Name

MS200095_0039

Description

This study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

Trial arms

Trial start

2018-05-14

Estimated PCD

2018-07-02

Trial end

2018-07-02

Status

Completed

Phase

Early phase I

Treatment

Tepotinib

Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.

Arms:

Sequence 1: Treatment A-B-C, Sequence 2: Treatment A-C-B, Sequence 3: Treatment B-A-C, Sequence 4: Treatment B-C-A, Sequence 5: Treatment C-A-B, Sequence 6: Treatment C-B-A

Omeprazole

Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.

Arms:

Sequence 1: Treatment A-B-C, Sequence 2: Treatment A-C-B, Sequence 3: Treatment B-A-C, Sequence 4: Treatment B-C-A, Sequence 5: Treatment C-A-B, Sequence 6: Treatment C-B-A

Size

Primary endpoint

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Tepotinib in Treatment A and Treatment C

Pre-dose, 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hour post-dose on Day 1 (for Treatment A) and on Day 5 (for Treatment C)

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib in Treatment A and Treatment C

Pre-dose, 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hour post-dose on Day 1 (for Treatment A) and on Day 5 (for Treatment C)

Maximum Observed Plasma Concentration (Cmax) of Tepotinib in Treatment A and Treatment C

Pre-dose, 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hour post-dose on Day 1 (for Treatment A) and on Day 5 (for Treatment C)

Eligibility criteria

Inclusion Criteria: * Healthy participants of non-child bearing potential * Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) * Body weight between 50 to 100 kilogram (kg) * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-07-28

1 organization

2 products

1 indication

Organization

Product

Indication

Product