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 AM1)
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | June 2012 |
End Date: | August 2013 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight/Obese Subjects and Patients With Type 2 Diabetes Mellitus
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).
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
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