A Study of the Safety, Tolerability, Pharmacokinetics, an... | NCT01614782

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
0.35 mg MK-5823 - Healthy Participants	Experimental	Drug: MK-5823 Other: Placebo
0.7 mg MK-5823 - Healthy Participants	Experimental	Drug: MK-5823 Other: Placebo
1.4 mg MK-5823 - Healthy Participants	Experimental	Drug: MK-5823 Other: Placebo
2.8 mg MK-5823 - Healthy Participants	Experimental	Drug: MK-5823 Other: Placebo
1.4 mg MK-5823 - Participants with T2DM	Experimental	Drug: MK-5823 Other: Placebo
2.8 mg MK-5823 - Participants with T2DM	Experimental	Drug: MK-5823 Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK-5823	Drug	MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Maximum plasma concentration (Cmax) following once daily administration of MK-5823

Eligibility Module

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

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases