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)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01614782
• Other study ID #: 5823-002
• Status: Terminated
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: February 3, 2016
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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.

Other:
• Placebo
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experienced at least one adverse event		Up to 49 days	Yes
Primary	Number of participants who discontinued from study drug due to an adverse event		Up to 21 days	Yes
Secondary	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	No
Secondary	Maximum plasma concentration (Cmax) following once daily administration of MK-5823		Predose on Day 1 (baseline) through 672 hours following the initial dose	No
Secondary	Lowest plasma concentration (Ctrough) following once daily administration of MK-5823		Predose on Day 1 (baseline) through 672 hours following the initial dose	No
Secondary	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	No
Secondary	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	No