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MK-0941 DFC

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Mar 23, 2015

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00567112Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)PHASE1 COMPLETED 18 — — Nov 1, 2007Apr 1, 2008Mar 23, 2015 - —
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Study Endpoints
Primary Endpoints
Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
From study drug administration to 72 hours post-administration
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
From study drug administration to 72 hours post-administration
Secondary Endpoints
AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
From study drug administration to 72 hours post-administration
Cmax of OCT (Fasted) and OCT (After Meal)
From study drug administration to 72 hours post-administration
Tmax for OCT (Fasted) and OCT (After Meal)
From study drug administration to 72 hours post-administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DFC (fasted)EXPERIMENTAL -
OCT (fasted)EXPERIMENTAL -
OCT (after meal)EXPERIMENTAL -
OCT (before meal)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
10 mg MK-0941 DFC (fasted)DRUGsingle dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
10 mg MK-0941 OCT (after meal)DRUGsingle dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal
10 mg MK-0941 OCT (before meal)DRUGsingle dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
10 mg MK-0941 OCT (fasted)DRUGsingle dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or females (of non-childbearing potential) between the ages of 18 to 70 * Participants have been diagnosed with Type 2 Diabetes * Participants are nonsmokers for at least 6 months Exclusion Criteria: * Participant should not be diagnosed with Type 1 diabetes * Particip...

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