A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject With Type 2 Diabetes
Overview
- Phase
- Phase 1
- Intervention
- MK-1006
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 24
- Primary Endpoint
- Number of Participants Who Experienced at Least One Adverse Event
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
Panel A: MK-1006 15/30/45
Participants 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.
Intervention: MK-1006
Panel A: MK-1006 15/30/45
Participants 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.
Intervention: Placebo
Panel B: MK-1006 60/80/60 fed
Participants 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.
Intervention: MK-1006
Panel B: MK-1006 60/80/60 fed
Participants 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.
Intervention: Placebo
Panel C: MK-1006 100/140/170
Participants 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.
Intervention: MK-1006
Panel C: MK-1006 100/140/170
Participants 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.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Who Experienced at Least One Adverse Event
Time Frame: 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
Time Frame: 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 Outcomes
- 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))
- Apparent Terminal Half-life (T 1/2) 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))
- 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))
- 24-hour Weighted Mean Glucose (WMG) Concentration(Up to 36 hours)
- Median Time to Maximum Plasma Concentration (Tmax) 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))