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MK-1708

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Merck & Company, Inc.|Trials Updated: Dec 18, 2024

MK-1708 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

MK-1708 clinical trials

MK-1708 · 1 trial · 1 indication

Phase 1 1
NCT06586606A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)Alzheimer's Disease
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
Predose and at designated timepoints up to approximately 2 weeks postdose

Blood samples will be collected to determine the AUC0-inf of MK-1708.

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 11 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Due to an AE
Up to approximately 11 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.

Secondary Endpoints

Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708
Predose and at designated timepoints up to approximately 2 weeks postdose
Maximum Plasma Concentration (Cmax) of MK-1708
Predose and at designated timepoints up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1708
Predose and at designated timepoints up to approximately 2 weeks postdose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1: MK-1708EXPERIMENTALParticipants will receive a single oral dose of MK-1708 on Day 1.
Period 2: MK-1708 and ItraconazoleEXPERIMENTALA washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.

Interventions

NameTypeDescription
MK-1708DRUGOral administration
ItraconazoleDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has...

Countries:United States
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Frequently asked questions about MK-1708

What is MK-1708?

MK-1708 is an investigational small molecule drug being developed by Merck & Company, Inc. (MRK) for Alzheimer's disease. It is in Phase 1 clinical development and has been studied in a drug interaction trial in healthy participants. It is not approved for any indication.

What is MK-1708 used for in Alzheimer's disease?

MK-1708 is being studied for Alzheimer's disease, a neurological condition. The clinical work completed so far was a Phase 1 drug interaction study conducted in healthy adult participants rather than in patients with Alzheimer's disease, so its use in patients remains under investigation.

Who makes MK-1708?

MK-1708 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for this asset.

What phase is MK-1708 in?

MK-1708 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early-stage clinical testing, and the drug is investigational rather than approved.

What clinical trials is MK-1708 in?

MK-1708 has been evaluated in one completed Phase 1 trial, NCT06586606, titled a study to evaluate the effects of itraconazole on MK-1708 in healthy participants. It enrolled 12 participants in the United States and was a controlled study in healthy volunteers.

Is MK-1708 FDA approved?

MK-1708 is not approved. It is an investigational small molecule in Phase 1 clinical development for Alzheimer's disease, and its only completed trial was a drug interaction study in healthy participants. Further clinical testing would be needed before any regulatory review.