A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Male or female of non-childbearing potential

• A Body Mass Index between 27 and 35 kg/m^2 and weighs at least 50 kg

• Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM

• For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin

• A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

• History of stroke, chronic seizures or major neurological disorder

• History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.

• History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)

• Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.

• History of neoplastic disease

• History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness

• Requires treatment with systemic or ocular corticosteroids

• For T2DM Panels, a history of hypoglycemic unawareness

• For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin

• For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation

• Unable to refrain from using any medication beginning 2 weeks before study participation

• Consumes excessive amounts of alcohol (>3 per day)

• Consumes more than 6 caffeinated beverages per day

• Had major surgery or donated or lost more than 1 unit of blood

• Participated in another investigational study within 4 weeks of study participation

• History of significant multiple and/or severe allergies or anaphylactic reaction

• Hypersensitivity to glucagon or insulin

• Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation

• Woman of child-bearing potential or is a nursing mother

• For T2DM Panels, age >50 years