Clinical trial NCT01614782: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of participants who experienced at least one adverse event
timeFrame: Up to 49 days
measure: Number of participants who discontinued from study drug due to an adverse event
timeFrame: Up to 21 days
Secondary outcomes:
measure: Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823
timeFrame: Predose on Day 1 (baseline) through 672 hours following the initial dose
measure: Maximum plasma concentration (Cmax) following once daily administration of MK-5823
timeFrame: Predose on Day 1 (baseline) through 672 hours following the initial dose
measure: Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
timeFrame: Predose on Day 1 (baseline) through 672 hours following the initial dose
measure: Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823
timeFrame: Predose on Day 1 (baseline) through 672 hours following the initial dose
measure: Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823
timeFrame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Other outcomes:
Locations:
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