A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy; Narcolepsy

Treatments: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619665

MK-6552-003 (Other Identifier)

6552-003

Details and patient eligibility

About

This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Criteria include but are not limited to the following:

• Is in good health
• Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive.

Exclusion criteria

Criteria include but are not limited to the following:

• History of or current hypertension,
• Has a history of sleep disorders:

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 6 patient groups

MK-6552-Placebo-Modafinil

Experimental group

Description:

Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552

MK-6552-Modafinil-Placebo

Experimental group

Description:

Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552

Placebo-Modafinil-MK-6552

Experimental group

Description:

Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552

Placebo-MK-6552-Modafinil

Experimental group

Description:

Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552

Modafinil-MK-6552-Plaebo

Experimental group

Description:

Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552

Modafinil-Plaebo-MK-6552

Experimental group

Description:

Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.

Treatment:

Drug: Modafinil placebo

Drug: Modafinil

Drug: MK-6552 placebo

Drug: MK-6552