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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00791661
Other study ID # 1006-005
Secondary ID 2008_584
Status Completed
Phase Phase 1
First received November 10, 2008
Last updated January 6, 2016
Start date November 2008
Est. completion date March 2009

Study information

Verified date January 2016
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 64 Years
Eligibility 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 clinical diagnosis of glaucoma

- Subject has donated blood or participated in another clinical study in the past 12 weeks

- Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MK-1006
MK-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.
Placebo
Matching placebo to MK-1006 in a single oral dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experienced at Least One Adverse Event 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. 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) Yes
Primary Number of Participants Who Discontinued Treatment Due to an Adverse Event 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. up to approximately 17 days Yes
Secondary Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-8]) After a Single Dose of MK-1006 AUC(0-8) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure. 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) No
Secondary Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure. 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) No
Secondary Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 The placebo group was not evaluated for this outcome measure. 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) No
Secondary Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 The placebo group was not evaluated for this outcome measure. 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) No
Secondary Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure. 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) No
Secondary 24-hour Weighted Mean Glucose (WMG) Concentration Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24. Up to 36 hours No
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