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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MK-1006 · 1 trial · 1 indication

Phase 1 1
NCT00791661MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)Diabetes Mellitus, Non-Insulin-Dependent
COMPLETED24 Analytics
PHASE1COMPLETED
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Diabetes Mellitus, Non-Insulin-DependentUnlock trial analytics

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 to 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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Frequently asked questions about MK-1006

What is MK-1006 used for?

MK-1006 is an investigational small molecule being developed for Type 2 Diabetes Mellitus and non-insulin-dependent diabetes mellitus. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with these conditions.

Who makes MK-1006?

MK-1006 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus and non-insulin-dependent diabetes mellitus.

What phase is MK-1006 in?

MK-1006 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one involving 25 patients with Type 2 Diabetes Mellitus and another involving 24 Japanese patients with non-insulin-dependent diabetes mellitus.

What clinical trials is MK-1006 in?

MK-1006 has completed two Phase 1 clinical trials. The first, NCT00757601, studied the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1006 in 25 patients with Type 2 Diabetes Mellitus. The second, NCT00791661, was a single-dose study in 24 Japanese patients with non-insulin-dependent diabetes mellitus.

Is MK-1006 the same as MK1006?

Yes, MK-1006 and MK1006 refer to the same investigational drug. Clinical trial NCT00757601 is titled 'A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)', confirming that both names are used interchangeably for this compound.