A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

Completed · Phase 1

Conditions studied: Healthy

In brief

The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.

Key facts

Study ID

NCT06719557

Run by

Merck Sharp & Dohme LLC

People needed

28

Starts

2024-05-20

Expected to finish

2024-07-30

Last updated by the study team

2026-02-11

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The main inclusion criteria include but are not limited to the following:
• Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• History of cancer (malignancy)
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
• Part 1 Only:
• History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
• Pat 2 Only:
• History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions

Where it is running

• Celerion (Site 0001) — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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