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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)

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ClinicalTrials.gov Identifier: NCT01614782
Recruitment Status : Terminated
First Posted : June 8, 2012
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MK-5823 Other: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 0.35 mg MK-5823 - Healthy Participants 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.
Experimental: 0.7 mg MK-5823 - Healthy Participants 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.
Experimental: 1.4 mg MK-5823 - Healthy Participants 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.
Experimental: 2.8 mg MK-5823 - Healthy Participants 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.
Experimental: 1.4 mg MK-5823 - Participants with T2DM 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.
Experimental: 2.8 mg MK-5823 - Participants with T2DM 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.


Outcome Measures

Primary Outcome Measures :
  1. Number of participants who experienced at least one adverse event [ Time Frame: Up to 49 days ]
  2. Number of participants who discontinued from study drug due to an adverse event [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ]
  2. Maximum plasma concentration (Cmax) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ]
  3. Lowest plasma concentration (Ctrough) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ]
  4. Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ]
  5. Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823 [ Time Frame: Predose on Day 1 (baseline) through 672 hours following the initial dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01614782     History of Changes
Other Study ID Numbers: 5823-002
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms