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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: MK-1006 DFC; Drug: MK-1006 FCT

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (ESTIMATE): September 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1006-010; 2009_663