Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-6552 · 3 trials · 2 indications
Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
Percentage of participants with at least one AE
Percentage of participants who discontinued from study due to an AE
Sleep latency of MWT for MK-6552 compared with placebo
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.
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.
Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil
Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil.
Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil.
| Arm | Type | Description |
|---|---|---|
| MK-6552 + Diltiazem | EXPERIMENTAL | Participants 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-Modafinil | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 + Modafinil | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| MK-6552 | DRUG | Oral Gelatin Coated Capsule |
| Diltiazem | DRUG | Oral Extended-Release Capsule |
| MK-6552 placebo | DRUG | MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart |
| Modafinil | DRUG | Modafinil tablet taken once orally |
| Modafinil placebo | DRUG | Modafinil placebo tablet taken once orally |
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...
MK-6552 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for neurology, studied in healthy participants and in conditions such as narcolepsy. It is currently in Phase 1 clinical development, with completed trials evaluating its effects in sleep-deprived healthy participants and in combination with other drugs.
MK-6552 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting Phase 1 clinical trials of this investigational small molecule in the United States, focusing on neurology and healthy volunteer studies.
MK-6552 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and all three of its clinical trials have been completed. These trials enrolled a total of 44 participants and were randomized, double-blind, and controlled studies.
MK-6552 has three completed Phase 1 trials: NCT06619665, a study in sleep-deprived healthy participants with narcolepsy; NCT06662396, a study of diltiazem with a single dose of MK-6552 in healthy adults; and NCT06665230, a study of MK-6552 and modafinil in healthy men. All were conducted in the United States.
No, MK-6552 is not the same as modafinil. MK-6552 is an investigational small molecule being developed by Merck, while modafinil is a separate drug used in a completed Phase 1 study (NCT06665230) to evaluate the effects of MK-6552 when administered together in healthy men.