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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00754130
Other study ID # 0941-011
Secondary ID 2008_023MK-0941-
Status Completed
Phase Phase 1
First received September 16, 2008
Last updated February 23, 2015
Start date September 2008
Est. completion date October 2008

Study information

Verified date February 2015
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

The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Japanese Male or Female between 20 to 65 years of age

- Diagnosis of Type 2 Diabetes

- Patient being treated by diet and exercise alone

Exclusion Criteria:

- Patient has a history of Type 1 Diabetes

- Patient is being treated with glaucoma medications

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

- Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse

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:
Placebo
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.

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 (AE) An AE 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.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Up to 14 days after last dose of study drug Yes
Primary Number of Participants Who Discontinued Study Drug Due to an AE An AE 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.
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Up to 14 days after last dose of study drug Yes
Secondary Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. Up to 72 hours after study drug administration No
Secondary Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. Up to 72 hours after study drug administration No
Secondary Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. Up to 72 hours after study drug administration No
Secondary Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. Up to 72 hours after study drug administration No
Secondary Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. Up to 72 hours after study drug administration No
Secondary Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr Geometric Mean of the Day 5 to Day 1 Accumulation Ratio Day 5 and Day 1 No
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