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MK-6552

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 30, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06662396A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)PHASE1 COMPLETED 14 — — Jun 13, 2024Sep 27, 2024Oct 28, 20241 United States
NCT06619665A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)PHASE1 COMPLETED 18 — — Mar 19, 2024Jul 16, 2024Oct 1, 20242 United States
NCT06665230A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)PHASE1 COMPLETED 12 — — Sep 20, 2023Nov 20, 2023Oct 30, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum Plasma Concentration (Cmax) of MK-6552
Pre-dose and at designated time points up to 24 hours post dose

Blood samples will be collected to determine the Cmax of MK-6552 in plasma.

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

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 1 month

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 19 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552
At designated timepoints (up to approximately 24 hours postdose)

Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs)
At designated timepoints (up to approximately 6 hours postdose)

Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs)
At designated timepoints (up to approximately 8 hours postdose)

Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil

High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil.

High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552
At designated timepoints (up to approximately 36 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil.

Secondary Endpoints
Number of Participants Who Experience and Adverse Event (AEs)
Up to approximately 20 days
Number of Participants Who Discontinue Study Due to an AE
Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
Pre-dose and at designated time points up to 96 hours post dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
MK-6552 + DiltiazemEXPERIMENTALParticipants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.
MK-6552-Placebo-ModafinilEXPERIMENTALParticipants 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-PlaceboEXPERIMENTALParticipants 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-6552EXPERIMENTALParticipants 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-ModafinilEXPERIMENTALParticipants 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-PlaeboEXPERIMENTALParticipants 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-6552EXPERIMENTALParticipants 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 + ModafinilEXPERIMENTALIn 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.
Interventions
NameTypeDescription
MK-6552DRUGOral Gelatin Coated Capsule
DiltiazemDRUGOral Extended-Release Capsule
MK-6552 placeboDRUGMK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart
ModafinilDRUGModafinil tablet taken once orally
Modafinil placeboDRUGModafinil placebo tablet taken once orally
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health before randomization * Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * His...

Countries:United States
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