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MK-8507

Phase 1

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

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
UNCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06619678A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)PHASE1 COMPLETED 36 — — Jan 17, 2024Jun 23, 2024Oct 1, 20241 United States
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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
ArmTypeDescription
Islatravir+MK-8507EXPERIMENTALPeriod 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
NameTypeDescription
MK-8507DRUGOral administration
IslatravirDRUGOral administration
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Eligibility Criteria
Age Range19 Years — 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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