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)
- Registration Number
- NCT01614782
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.35 mg MK-5823 - Healthy Participants Placebo - 0.7 mg MK-5823 - Healthy Participants MK-5823 - 0.7 mg MK-5823 - Healthy Participants Placebo - 0.35 mg MK-5823 - Healthy Participants MK-5823 - 1.4 mg MK-5823 - Healthy Participants Placebo - 2.8 mg MK-5823 - Healthy Participants Placebo - 1.4 mg MK-5823 - Participants with T2DM Placebo - 2.8 mg MK-5823 - Participants with T2DM MK-5823 - 2.8 mg MK-5823 - Participants with T2DM Placebo - 1.4 mg MK-5823 - Healthy Participants MK-5823 - 2.8 mg MK-5823 - Healthy Participants MK-5823 - 1.4 mg MK-5823 - Participants with T2DM MK-5823 -
- Primary Outcome Measures
Name Time Method Number of participants who experienced at least one adverse event Up to 49 days Number of participants who discontinued from study drug due to an adverse event Up to 21 days
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) following once daily administration of MK-5823 Predose on Day 1 (baseline) through 672 hours following the initial dose Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823 Predose on Day 1 (baseline) through 672 hours following the initial dose Lowest plasma concentration (Ctrough) following once daily administration of MK-5823 Predose on Day 1 (baseline) through 672 hours following the initial dose Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823 Predose on Day 1 (baseline) through 672 hours following the initial dose Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823 Predose on Day 1 (baseline) through 672 hours following the initial dose