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Completed
NCT07838987
A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
Conditions: Healthy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 196
Sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Location: ICON Millcreek Utah
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
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m\^2 (inclusive)
* Is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
* Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
* Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
* Has any known history of bleeding, or prothrombin time (Embibatinib + Probe Substrate Cocktail-2 arm only)
Source: ClinicalTrials.gov (NCT07838987). StuddyBuddy aggregates publicly available trial information.