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MK-1006 DFC

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Feb 5, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00979459A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)PHASE1 COMPLETED 12Sep 1, 2009Dec 1, 2009Feb 5, 2016 -
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Study Endpoints
Primary Endpoints
Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose

AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC

Maximum Plasma Concentration (Cmax) for MK-1006
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose

Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC

Secondary Endpoints
Number of Participants Who Experienced at Least One Adverse Event
Through 30 days post-dose
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
up to 8 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-1006 80 mg DFCEXPERIMENTALParticipants received a single dose of four 20 mg dry filled capsules of MK-1006
MK-1006 80 mg FCTEXPERIMENTALParticipants received a single dose of two 40 mg film coated tablets of MK-1006
Interventions
NameTypeDescription
MK-1006 DFCDRUGEach dry filled capsule contains 20 mg MK-1006
MK-1006 FCTDRUGEach film coated tablet contains 40 mg of MK-1006
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * is a male or a female of non-child bearing potential * has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s) * has been a nonsmoker for at least 6 months Exclusion Criteria: * has a...

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