| Trial ID: | L2133 |
| Source ID: | NCT01614782
|
| Associated Drug: |
Mk-5823
|
| 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)
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: MK-5823|OTHER: Placebo
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-06
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-02-05
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT01614782
|
