Back to resultsA 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)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-5823
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
0.35 mg MK-5823 - Healthy Participants
0.7 mg MK-5823 - Healthy Participants
1.4 mg MK-5823 - Healthy Participants
2.8 mg MK-5823 - Healthy Participants
1.4 mg MK-5823 - Participants with T2DM
2.8 mg MK-5823 - Participants with T2DM
Arm Description
Outcomes
Primary Outcome Measures
Number of participants who experienced at least one adverse event
Number of participants who discontinued from study drug due to an adverse event
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
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823
Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01614782
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.35 mg MK-5823 - Healthy Participants
Arm Type
Experimental
Arm Title
0.7 mg MK-5823 - Healthy Participants
Arm Type
Experimental
Arm Title
1.4 mg MK-5823 - Healthy Participants
Arm Type
Experimental
Arm Title
2.8 mg MK-5823 - Healthy Participants
Arm Type
Experimental
Arm Title
1.4 mg MK-5823 - Participants with T2DM
Arm Type
Experimental
Arm Title
2.8 mg MK-5823 - Participants with T2DM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MK-5823
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
Primary Outcome Measure Information:
Title
Number of participants who experienced at least one adverse event
Time Frame
Up to 49 days
Title
Number of participants who discontinued from study drug due to an adverse event
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
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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