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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: MK-1006 DFC

Drug: MK-1006 FCT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00979459

2009_663

1006-010

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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