A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.

Official Title
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A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: MK-1006 DFC
* Drug: MK-1006 FCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is a male or a female of non-child bearing potential has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s) has been a nonsmoker for at least 6 months Exclusion Criteria: has a history of stroke, chronic seizures, or major neurological disorder has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening has unstable or rapidly progressing diabetic retinopathy and/or neuropathy has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening has glaucoma or is blind has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted) has a history of type 1 diabetes has symptomatic coronary artery disease consumes excessive amounts of alcohol and/or caffeine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-1006 80 mg DFC<br>Participants received a single dose of four 20 mg dry filled capsules of MK-1006 | Drug: MK-1006 DFC<br>* Each dry filled capsule contains 20 mg MK-1006<br>|
| Experimental: MK-1006 80 mg FCT<br>Participants received a single dose of two 40 mg film coated tablets of MK-1006 | Drug: MK-1006 FCT<br>* Each film coated tablet contains 40 mg of MK-1006<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose | 
| Maximum Plasma Concentration (Cmax) for MK-1006 | Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced at Least One Adverse Event |  | Through 30 days post-dose | 
| Number of Participants Who Discontinued Study Medication Due to an Adverse Event |  | up to 8 days |