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 AM1)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01614782
First received: June 6, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-5823
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who experienced at least one adverse event [ Time Frame: Up to 49 days ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued from study drug due to an adverse event [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01614782     History of Changes
Other Study ID Numbers: 5823-002
Study First Received: June 6, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014