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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK-1006 DFC; Drug: MK-1006 FCT

• Registration Number: NCT00979459
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2012-07-12
• Results First Submitted QC: 2012-07-12
• Results First Posted: 2012-08-20
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MK-1006 80 mg DFC	MK-1006 DFC	Participants received a single dose of four 20 mg dry filled capsules of MK-1006
MK-1006 80 mg FCT	MK-1006 FCT	Participants received a single dose of two 40 mg film coated tablets of MK-1006

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006	Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose	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
Maximum Plasma Concentration (Cmax) for MK-1006	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 for 2 formulations of MK-1006, FCT and DFC

Secondary Outcome Measures

Name	Time	Method
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