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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979459
• Other study ID #: 1006-010
• Secondary ID: 2009_663
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: February 4, 2016
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• MK-1006 DFC
Each dry filled capsule contains 20 mg MK-1006
• MK-1006 FCT
Each film coated tablet contains 40 mg of MK-1006

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of Participants Who Experienced at Least One Adverse Event		Through 30 days post-dose	Yes
Secondary	Number of Participants Who Discontinued Study Medication Due to an Adverse Event		up to 8 days	Yes