Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

• Status: Completed
• Trial end date: 2012-12-20
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Male or female of non-child bearing potential

• Body Mass Index ≤40 kg/m^2

• Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only

• In good health except for T2DM

• Willing to follow a standard diet

• Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

Exclusion Criteria:

• Mentally or legally incapacitated

• History of stroke, chronic seizures, or major neurological disorder

• History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

• History of neoplastic or myeloproliferative diseases

• Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety

• Has a history of Type 1 Diabetes and/or history of ketoacidosis

• Use of any lipid-lowering therapies in the past 3 months

• Non-permitted medication for a co-morbid condition

• Excessive alcohol or caffeine use

• Participation in another investigational study within 4 weeks prior to this study

• A history of significant multiple and/or severe allergies or anaphylactic reactions

• Regular user of any illicit drugs or history of alcohol abuse within 6 months