A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy; Narcolepsy

Treatments: Drug: Modafinil; Drug: MK-6552

Study type: Interventional

Funder types: Industry

Identifiers

NCT06665230

6552-005

MK-6552-005 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

• Is in good health based on medical history and physical examination
• Has a body mass index ≥18 and ≤32 kg/m^2, inclusive

Exclusion Criteria

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

• Has a history of clinically significant endocrine, gastrointestinal, 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

MK-6552 + Modafinil

Experimental group

Description:

In Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally.

Treatment:

Drug: MK-6552

Drug: Modafinil