Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1167 · 5 trials · 2 indications
Blood samples will be collected to determine the AUC0-inf of MK-1167.
Blood samples will be collected to determine the Cmax of MK-1167.
Blood samples will be collected to determine the AUC0-last of MK-1167.
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. The number of participants who experience an AE will be reported.
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. The number of participants who discontinue study treatment due to an AE will be reported.
An AE was 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 can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
An AE was 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 can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE were reported.
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.
AUC0-inf of MK-1167 in plasma will be determined.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Blood samples will be collected to determine the AUC0-24 of MK-1167.
Blood samples will be collected to determine the Cmax of MK-1167.
Blood samples will be collected to determine the C24 of MK-1167.
Blood samples will be collected to determine the Tmax of MK-1167.
Blood samples will be collected to determine the CL/F of MK-1167.
Blood samples will be collected to determine the Vz/F of MK-1167.
Blood samples will be collected to determine the t½ of MK-1167.
| Arm | Type | Description |
|---|---|---|
| Arm 1: MK-1167 Form 2 | EXPERIMENTAL | Participants receive MK-1167 Form 2 orally. |
| Arm 2: MK-1167 Form 1 | EXPERIMENTAL | Participants receive MK-1167 Form 1 orally. |
| MK-1167 | EXPERIMENTAL | MK-1167 administered orally |
| Placebo | PLACEBO_COMPARATOR | Placebo for MK-1167 administered orally |
| Panel A: MK-1167 + Donepezil 10mg QD | EXPERIMENTAL | Participants receive 6mg MK-1167 oral loading doses once daily (QD) Days 1 to 7, followed by 3mg MK-1167 oral maintenance doses QD Days 8 to 21. Participants also receive 10mg oral Donepezil on Days -3 to 21. |
| Panel A: Placebo to MK-1167 + Donepezil 10mg QD | PLACEBO_COMPARATOR | Participants receive dose matched placebo to MK-1167 oral QD from Days 1 to 21. Participants also receive 10mg oral Donepezil QD on Days -3 to 21. |
| Panel B: MK-1167 6mg QD + Donepezil 10mg QD | EXPERIMENTAL | Participants receive 6mg MK-1167 oral doses QD Days 1 to 31. Participants also receive 10mg oral Donepezil on Days -3 to 31. |
| Panel B: Placebo to MK-1167 + Donepezil 10mg QD | PLACEBO_COMPARATOR | Participants receive dose matched placebo to MK-1167 oral QD from Days 1 to 31. Participants also receive 10mg oral Donepezil QD on Days -3 to 31. |
| MK-1167 Period 1 | EXPERIMENTAL | On Day 1 a single dose of MK-1167 will be administered. |
| MK-1167 Period 2 | EXPERIMENTAL | There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3. |
| Panel A | EXPERIMENTAL | Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16. |
| Panel B | EXPERIMENTAL | Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16. |
| Name | Type | Description |
|---|---|---|
| MK-1167 | DRUG | Oral administration |
| Placebo | DRUG | Oral capsule administered once daily |
| Donepezil | DRUG | 10 mg oral tablets |
| Diltiazem | DRUG | Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules. |
Inclusion Criteria: * Is in good health * Has a body mass index (BMI) ≥18 and ≤ 32 kg/m\^2, inclusive Exclusion Criteria: * Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neuro...
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MK-1167 is an investigational small molecule being studied for Alzheimer's Disease and in healthy participants. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation.
MK-1167 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 1 clinical trials of this investigational small molecule in the United States for Alzheimer's Disease and in healthy participants.
MK-1167 is in Phase 1 clinical development. All four clinical trials for this investigational drug have been completed, with no active trials currently ongoing. The drug is not FDA approved and remains under investigation for Alzheimer's Disease.
MK-1167 has completed four Phase 1 clinical trials. These include NCT06285240 in Alzheimer's Disease patients on stable donepezil, NCT06625840 in healthy elderly participants, NCT06703463 a drug-drug interaction study with diltiazem, and NCT07334860 comparing different forms of the drug in healthy people.
Yes, MK-1167 is being studied in Alzheimer's Disease. One completed Phase 1 trial, NCT06285240, evaluated the efficacy and safety of MK-1167 in participants with Alzheimer's Disease dementia who were taking stable donepezil treatment. This trial enrolled 28 participants in the United States.
A total of 78 participants have been enrolled across four completed Phase 1 clinical trials of MK-1167. These trials were randomized, double-blind, and placebo-controlled, and were conducted in the United States.