A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
Phase 1
Completed
- Conditions
- HealthyNarcolepsy
- Interventions
- Registration Number
- NCT06619665
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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:
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo-Modafinil-MK-6552 Modafinil placebo 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. MK-6552-Placebo-Modafinil MK-6552 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. MK-6552-Placebo-Modafinil MK-6552 placebo 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. MK-6552-Placebo-Modafinil Modafinil placebo 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. MK-6552-Modafinil-Placebo MK-6552 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. MK-6552-Modafinil-Placebo MK-6552 placebo 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. MK-6552-Modafinil-Placebo Modafinil placebo 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. Placebo-Modafinil-MK-6552 MK-6552 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. Placebo-Modafinil-MK-6552 MK-6552 placebo 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. Placebo-MK-6552-Modafinil MK-6552 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. Placebo-MK-6552-Modafinil MK-6552 placebo 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. Placebo-MK-6552-Modafinil Modafinil placebo 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. Modafinil-MK-6552-Plaebo MK-6552 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. Modafinil-MK-6552-Plaebo MK-6552 placebo 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. Modafinil-MK-6552-Plaebo Modafinil placebo 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. Modafinil-Plaebo-MK-6552 MK-6552 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. Modafinil-Plaebo-MK-6552 MK-6552 placebo 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. Modafinil-Plaebo-MK-6552 Modafinil placebo 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. MK-6552-Placebo-Modafinil Modafinil 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. MK-6552-Modafinil-Placebo Modafinil 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. Placebo-Modafinil-MK-6552 Modafinil 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. Placebo-MK-6552-Modafinil Modafinil 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. Modafinil-MK-6552-Plaebo Modafinil 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. Modafinil-Plaebo-MK-6552 Modafinil 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.
- Primary Outcome Measures
Name Time Method Participants with an Adverse Event (AE) Up to Day 30 Percentage of participants with at least one AE
Participants who discontinued from study due to an AE Day 1 Percentage of participants who discontinued from study due to an AE
Maintenance of Wakefulness Test (MWT) for MK-6552 Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose) Sleep latency of MWT for MK-6552 compared with placebo
- Secondary Outcome Measures
Name Time Method Concentration of plasma MK-6552 24 hours (C24h) after first dose 24 hours C24h of plasma MK-6552 after first dose
MWT for Modafinil 2 hours postdose Sleep latency of MWT for Modafinil compared with placebo
Area under the concentration=time curve (AUC) for plasma MK-6552 At designated timepoints up to 24 hours postdose AUC for plasma MK-6552 from 0-24 hours postdose
Concentration of plasma MK-6522 at Tmax following morning (AM) dose Tmax following AM dose (at designated timepoints up to 24 hours postdose) Plasma concentration of MK-6552 at Tmax following AM dose
Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose Tmax following PM dose (at designated timepoints up to 24 hours postdose) Plasma concentration of MK-6552 at Tmax following PM dose
Concentration of plasma MK-6552 8 hours (C8h) after first dose 8 hours C8h of plasma MK-6552 after first dose
Trial Locations
- Locations (2)
NeuroTrials Research Inc (Site 0001)
🇺🇸Atlanta, Georgia, United States
Clinilabs (Site 0003)
🇺🇸Eatontown, New Jersey, United States