A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: MK-1708; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586606

MK-1708-003 (Other Identifier)

1708-003

Details and patient eligibility

About

The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18.5 and ≤32 kg/m^2, inclusive

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Period 1: MK-1708

Experimental group

Description:

Participants will receive a single oral dose of MK-1708 on Day 1.

Treatment:

Drug: MK-1708

Period 2: MK-1708 and Itraconazole

Experimental group

Description:

A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.

Treatment:

Drug: Itraconazole

Drug: MK-1708