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)
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
1 other identifier
interventional
24
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Jun 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 5, 2016
February 1, 2016
4 months
June 6, 2012
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants who experienced at least one adverse event
Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
Up to 21 days
Secondary Outcomes (5)
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
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
Predose on Day 1 (baseline) through 672 hours following the initial dose
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
Predose on Day 1 (baseline) through 672 hours following the initial dose
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
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
Study Arms (6)
0.35 mg MK-5823 - Healthy Participants
EXPERIMENTAL0.7 mg MK-5823 - Healthy Participants
EXPERIMENTAL1.4 mg MK-5823 - Healthy Participants
EXPERIMENTAL2.8 mg MK-5823 - Healthy Participants
EXPERIMENTAL1.4 mg MK-5823 - Participants with T2DM
EXPERIMENTAL2.8 mg MK-5823 - Participants with T2DM
EXPERIMENTALInterventions
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.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 5, 2016
Record last verified: 2016-02