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MK-1006

Phase 1

Diabetes Mellitus, Non-Insulin-Dependent | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jan 7, 2016

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-BlindCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00791661MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)PHASE1 COMPLETED 24 — — Nov 1, 2008Mar 1, 2009Jan 7, 2016 - —
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Study Endpoints
Primary Endpoints
Number of Participants Who Experienced at Least One Adverse Event
from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

Number of Participants Who Discontinued Treatment Due to an Adverse Event
up to approximately 17 days

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

Secondary Endpoints
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel A: MK-1006 15/30/45EXPERIMENTALParticipants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Panel B: MK-1006 60/80/60 fedEXPERIMENTALParticipants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Panel C: MK-1006 100/140/170EXPERIMENTALParticipants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
Interventions
NameTypeDescription
MK-1006DRUGMK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.
PlaceboDRUGMatching placebo to MK-1006 in a single oral dose
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Eligibility Criteria
Age Range20 Years — 64 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Japanese male or female between 20 to 64 years of age * Diagnosis of type 2 diabetes * Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent Exclusion Criteria: * Subject has a history of type 1 diabetes mellitus * Subject has a clinic...

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