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MK-8507

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 1, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED

Total Trials1

Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

MK-8507 · 1 trial · 1 indication

Phase 1 1

NCT06619678A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)Healthy

COMPLETED36 Analytics

PHASE1COMPLETED

A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)

Healthy

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Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite

At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.

Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite

At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.

Maximum Concentration (Cmax) of Islatravir Metabolite

At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine Cmax of Islatravir metabolite.

Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite

At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of Islatravir metabolite.

Time to Maximum Concentration (Tmax) of Islatravir Metabolite

At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the Tmax of Islatravir metabolite.

Apparent Terminal Half-life (t1/2) of Islatravir Metabolite

At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the t1/2 of Islatravir metabolite.

AUC0-Inf of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the AUC0-Inf of Islatravir.

AUC0-168hrs of Islatravir

At designated timepoints (up to approximately 7 days)

Blood samples will be collected to determine the AUC0-168hrs of Islatravir.

Cmax of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine Cmax of Islatravir.

C168 of Islatravir

At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of Islatravir.

Tmax of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the Tmax of Islatravir.

t1/2 of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the t1/2 of Islatravir.

Apparent clearance (CL/F) of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the CL/F of Islatravir.

Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir

At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the Vd/F of Islatravir.

AUC0-168hrs of MK-8507

At designated timepoints (up to approximately 7 days)

Blood samples will be collected to determine the AUC0-168hrs of MK-8507.

Cmax of MK-8507

At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine Cmax of MK-8507.

C168 of MK-8507

At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of MK-8507.

Tmax of MK-8507

At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the Tmax of MK-8507.

t1/2 of MK-8507

At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the t1/2 of MK-8507.

CL/F of MK-8507

At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the CL/F of MK-8507.

Vd/F of MK-8507

At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the Vd/F of MK-8507.

Secondary Endpoints

Number of Participants Who Experience an Adverse Event (AE)

Up to approximately 5 months

Number of Participants Who Discontinue Study Treatment Due to an AE

Up to approximately 5 months

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Islatravir+MK-8507	EXPERIMENTAL	Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29.

Interventions

Name	Type	Description
MK-8507	DRUG	Oral administration
Islatravir	DRUG	Oral administration

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Eligibility Criteria

Age Range19 Years to 65 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 and ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a...

Countries:United States

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Frequently asked questions about MK-8507

What is MK-8507?

MK-8507 is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development. The drug has been studied in healthy adult participants, and its therapeutic area is classified as Other.

What is MK-8507 used for?

MK-8507 is being studied for use in healthy adult participants. It is an investigational small molecule in Phase 1 clinical development. The drug has not been approved for any indication and remains in early-stage clinical testing.

Who makes MK-8507?

MK-8507 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug in healthy participants.

What phase is MK-8507 in?

MK-8507 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is still in early-stage testing, with one completed Phase 1 trial.

What clinical trials is MK-8507 in?

MK-8507 has been studied in one clinical trial, NCT06619678, titled "A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)." This Phase 1 trial was completed in the United States and enrolled 36 healthy participants.

Is MK-8507 the same as islatravir?

No, MK-8507 is not the same as islatravir (MK-8591). They are distinct investigational drugs that were studied together in a clinical trial. The trial, NCT06619678, evaluated MK-8507 in combination with islatravir in healthy adult participants.