Clinical trial NCT00791661: MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Official title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: 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)
measure: Number of Participants Who Discontinued Treatment Due to an Adverse Event
timeFrame: up to approximately 17 days
Secondary outcomes:
measure: Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
timeFrame: 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)
measure: Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
timeFrame: 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)
measure: Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
timeFrame: 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)
measure: Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006
timeFrame: 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)
measure: Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006
timeFrame: 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)
measure: 24-hour Weighted Mean Glucose (WMG) Concentration
timeFrame: Up to 36 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: