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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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