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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

MK-0941 DFC · 1 trial · 1 indication

Phase 1 1
NCT00567112Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)Type 2 Diabetes Mellitus
COMPLETED18 Analytics
PHASE1COMPLETED
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Type 2 Diabetes MellitusUnlock trial analytics

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 to 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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Frequently asked questions about MK-0941 DFC

What is MK-0941 DFC used for?

MK-0941 DFC is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes MK-0941 DFC?

MK-0941 DFC is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company conducted a Phase 1 clinical trial of the drug in adults with Type 2 Diabetes Mellitus.

What phase is MK-0941 DFC in?

MK-0941 DFC is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MK-0941 DFC in?

MK-0941 DFC has been studied in one completed Phase 1 clinical trial, identified as NCT00567112. The trial, titled "Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)," enrolled 18 participants and was active-controlled but not double-blinded.

What does MK-0941 DFC target?

The molecular target of MK-0941 DFC has not been disclosed in available information. The drug is a small molecule being investigated for its effects on Type 2 Diabetes Mellitus, but its specific mechanism of action is not publicly detailed.