Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-6552 · 2 trials · 2 indications
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-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 | MK-6552 gelatin coated capsules taken orally two times 8 hours apart |
| 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: 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 ...
MK-6552 is an investigational small molecule being developed by Merck & Company, Inc. for narcolepsy, a neurological sleep disorder. It is in Phase 1 clinical development and has been studied in two completed Phase 1 trials, both conducted in the United States.
MK-6552 is being developed as a potential treatment for narcolepsy, a neurological condition. It is investigational and has not been approved for any use. The completed Phase 1 trials enrolled healthy participants and listed narcolepsy among the conditions studied.
MK-6552 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the two completed Phase 1 clinical trials of the drug.
MK-6552 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
MK-6552 has been studied in two completed Phase 1 trials. NCT06665230 evaluated MK-6552 and modafinil in 12 healthy men. NCT06619665 studied MK-6552 in 18 sleep deprived healthy participants. Both trials were conducted in the United States.
No, MK-6552 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for narcolepsy. Both of its Phase 1 trials have been completed, and no active trials are currently listed.