A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Itraconazole; Drug: MK-2828

Study type: Interventional

Funder types: Industry

Identifiers

NCT07435194

MK-2828-007 (Other Identifier)

2828-007

Details and patient eligibility

About

The main goals of this study are:

• To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole
• To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828

Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.

Enrollment: 29 patients

Sex: All

Ages: 24 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

- Participant is in good health

Exclusion criteria

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

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Part 1: Itraconazole

Experimental group

Description:

Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.

Treatment:

Drug: MK-2828

Drug: Itraconazole

Part 2: Midazolam

Experimental group

Description:

Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.

Treatment:

Drug: MK-2828

Drug: Midazolam