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)

NCT ID: NCT01614782

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-10-31

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).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.35 mg MK-5823 - Healthy Participants

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

0.7 mg MK-5823 - Healthy Participants

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

1.4 mg MK-5823 - Healthy Participants

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

2.8 mg MK-5823 - Healthy Participants

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

1.4 mg MK-5823 - Participants with T2DM

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

2.8 mg MK-5823 - Participants with T2DM

Group Type: EXPERIMENTAL

MK-5823

Intervention Type: 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.

Placebo

Intervention Type: OTHER

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

Interventions

MK-5823

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.

Intervention Type: DRUG

Placebo

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

5823-002

Identifier Type: -

Identifier Source: org_study_id