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MK-1167

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Apr 28, 2026

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-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07334860A Clinical Trial to Compare Forms of MK-1167 in Healthy People (MK-1167-011)PHASE1 ACTIVE NOT_RECRUITING 16Feb 6, 2026May 28, 2026Mar 19, 20261 United States
NCT07266818A Clinical Trial of MK-1167 in Healthy Adults (MK-1167-010)PHASE1 COMPLETED 30Dec 18, 2025Apr 9, 2026Apr 28, 20261 United States
NCT06703463A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)PHASE1 COMPLETED 16Oct 17, 2023Feb 2, 2024Nov 25, 20241 United States
NCT06625840A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)PHASE1 COMPLETED 16Sep 18, 2023May 8, 2024Oct 3, 20241 United States
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Study Endpoints
Primary Endpoints
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167
At designated time points (up to approximately 21 days)

Blood samples will be collected to determine the AUC0-inf of MK-1167.

Maximum Plasma Concentration (Cmax) of MK-1167
At designated time points (up to approximately 21 days)

Blood samples will be collected to determine the Cmax of MK-1167.

Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167
At designated time points (up to approximately 21 days)

Blood samples will be collected to determine the AUC0-last of MK-1167.

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 9 weeks

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.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 1 week

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.

Number of participants who experience one or more adverse events (AEs)
Up to approximately 99 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.

Number of participants who discontinue study intervention due to an AE
Up to approximately 85 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.

Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
Predose, and at designated timepoints up to 50 days post-dose

AUC0-inf of MK-1167 in plasma will be determined.

Number of Participants Experiencing an Adverse Event (AE)
Up to approximately 41 days

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.

Number of Participants Discontinuing Study Treatment due to an AE
Up to approximately 16 days

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.

Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses
Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16

Blood samples will be collected to determine the AUC0-24 of MK-1167.

Maximum Concentration (Cmax) of MK-1167 after Multiple Doses
Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16

Blood samples will be collected to determine the Cmax of MK-1167.

Concentration at 24 hours (C24) of MK-1167 after Multiple Doses
24 hours postdose on days 1, 8 and 16

Blood samples will be collected to determine the C24 of MK-1167.

Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses
Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16

Blood samples will be collected to determine the Tmax of MK-1167.

Apparent Clearance (CL/F) of MK-1167 after Multiple Doses
Predose and at designated timepoints up to 600 hours postdose on day 16

Blood samples will be collected to determine the CL/F of MK-1167.

Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses
Predose and at designated timepoints up to 600 hours postdose on day 16

Blood samples will be collected to determine the Vz/F of MK-1167.

Apparent Half Life (t½) of MK-1167 after Multiple Doses
Predose and at designated timepoints up to 600 hours postdose on day 16

Blood samples will be collected to determine the t½ of MK-1167.

Secondary Endpoints
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167
At designated time points (up to approximately 24 hours)
Concentration at 24 hours (C24) of MK-1167
At designated time points (up to approximately 24 hours)
Time to Maximum Serum Concentration (Tmax) of MK-1167
At designated time points (up to approximately 21 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Arm 1: MK-1167 Form 2EXPERIMENTALParticipants receive MK-1167 Form 2 orally.
Arm 2: MK-1167 Form 1EXPERIMENTALParticipants receive MK-1167 Form 1 orally.
MK-1167EXPERIMENTALMK-1167 administered orally
PlaceboPLACEBO_COMPARATORPlacebo for MK-1167 administered orally
MK-1167 Period 1EXPERIMENTALOn Day 1 a single dose of MK-1167 will be administered.
MK-1167 Period 2EXPERIMENTALThere 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 AEXPERIMENTALParticipants 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 BEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
MK-1167DRUGOral administration
PlaceboDRUGOral capsule administered once daily
DiltiazemDRUGDiltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 29, 2026NCT07266818TRIAL_REMOVED: changed
MEDIUMMay 29, 2026NCT07266818TRIAL_REMOVED: changed
MEDIUMMay 29, 2026NCT07266818TRIAL_REMOVED: changed
LOWMay 26, 2026NCT07334860primaryCompletionDate: changed
HIGHMay 26, 2026NCT07266818Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT07266818studyFirstPostDate: changed
LOWMay 24, 2026NCT07334860studyFirstPostDate: changed