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A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
Sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Summary
The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time. Researchers will compare what happens to different doses and forms of Embibatinib in a person's body over time when given with or without food, or with or without other medications. The goal of the study is to learn: * What happens to different doses of Embibatinib in a person's body over time when it is given with or without food, or with or without other medications. * About the safety of Embibatinib and if people tolerate it
Official title: A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2023-12-21
Completion Date
2026-06-30
Last Updated
2026-10-22
Healthy Volunteers
Yes
Conditions
Interventions
Embibatinib
Oral Tablet
Rabeprazole
The United States commercially marketed 20 mg oral tablet formulation is being used in this trial.
Midazolam
2 mg oral syrup formulation administered as part of the probe substrate cocktail-1 and probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
Digoxin
0.25 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
Pravastatin
40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
Montelukast
10 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
Omeprazole
40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.
Itraconazole
The United States commercially marketed 200 mg oral capsule formulation is being used in this trial.
Warfarin
5 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
Rosuvastatin
10 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.
Bosentan
The Europe commercially marketed 125 mg oral tablet formulation is being used in this trial.
Quinidine
The United States commercially marketed 300 mg oral tablet formulation is being used in this trial.
Locations (1)
ICON
Millcreek, Utah, United States