NCT01614782
Terminated
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- MK-5823
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 24
- Primary Endpoint
- Number of participants who experienced at least one adverse event
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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).
Investigators
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
Arms & Interventions
0.35 mg MK-5823 - Healthy Participants
Intervention: MK-5823
1.4 mg MK-5823 - Participants with T2DM
Intervention: MK-5823
0.35 mg MK-5823 - Healthy Participants
Intervention: Placebo
0.7 mg MK-5823 - Healthy Participants
Intervention: MK-5823
0.7 mg MK-5823 - Healthy Participants
Intervention: Placebo
1.4 mg MK-5823 - Healthy Participants
Intervention: MK-5823
1.4 mg MK-5823 - Healthy Participants
Intervention: Placebo
2.8 mg MK-5823 - Healthy Participants
Intervention: MK-5823
2.8 mg MK-5823 - Healthy Participants
Intervention: Placebo
1.4 mg MK-5823 - Participants with T2DM
Intervention: Placebo
2.8 mg MK-5823 - Participants with T2DM
Intervention: MK-5823
2.8 mg MK-5823 - Participants with T2DM
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants who experienced at least one adverse event
Time Frame: Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
Time Frame: Up to 21 days
Secondary Outcomes
- Maximum plasma concentration (Cmax) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
- 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)
- 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)
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