MedDataX Logo

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

NCT ID: NCT06719557

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: MK-1084 + Itraconazole

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.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

Itraconazole

Intervention Type DRUG

Oral solution

Part 2: MK-1084 + Phenytoin

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.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

Phenytoin

Intervention Type DRUG

Oral capsule (extended)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MK-1084

Oral Tablet

Intervention Type DRUG

Itraconazole

Oral solution

Intervention Type DRUG

Phenytoin

Oral capsule (extended)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Celerion (Site 0001)

Lincoln, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK-1084-008

Identifier Type: OTHER

Identifier Source: secondary_id

CA43207

Identifier Type: OTHER

Identifier Source: secondary_id

1084-008

Identifier Type: -

Identifier Source: org_study_id