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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MK-1084; Drug: Itraconazole; Drug: Phenytoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06719557

MK-1084-008 (Other Identifier)

CA43207 (Other Identifier)

1084-008

Details and patient eligibility

About

The goal of this study is to learn what happens to MK-1084 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of MK-1084 when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.

Enrollment: 28 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Part 1: MK-1084 + Itraconazole

Experimental group

Description:

Part 1: In Period 1 participants receive a single dose of MK-1084 on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of MK-1084 administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.

Treatment:

Drug: Itraconazole

Drug: MK-1084

Part 2: MK-1084 + Phenytoin

Experimental group

Description:

Part 2: In Period 1 participants receive a single dose of MK-1084 on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of MK-1084 co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.

Treatment:

Drug: Phenytoin

Drug: MK-1084