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MK-3102

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Sep 10, 2018

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01767688A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)PHASE1 COMPLETED 16 — — Jan 16, 2013Mar 7, 2013Sep 10, 2018 - —
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Secondary Endpoints
Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Plasma Concentration at 168 Hours After Dosing (C168h)
168 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Moderate Hepatic Impairment GroupEXPERIMENTAL -
Healthy Matched Control GroupEXPERIMENTAL -
Interventions
NameTypeDescription
MK-3102DRUGSingle dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Impaired Hepatic Function Participants: * A diagnosis of: 1. Chronic (\> 6 months) hepatic insufficiency 2. Stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to a...

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