| Trial ID: | L4096 |
| Source ID: | NCT02269735
|
| Associated Drug: |
Mk-2640
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| Title: |
A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: MK-2640|BIOLOGICAL: Regular Human Insulin (RHI)|DRUG: Dextrose|BIOLOGICAL: Insulin aspart|DRUG: Rescue medication
|
| Outcome Measures: |
Primary: Number of participants who experienced an adverse event, Up to 30 days following last dose|Pharmacokinetic parameter: steady state plasma concentration (Css), Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval|Pharmacokinetic parameter: area under the plasma concentration curve from time 0 to infinity (AUC [0 to infinity]), Part I: 18 time points between predose and 600 minutes (min.); Part II: 19 time points between predose and 535 min.; Part III: 18 time points between predose and 415 min. following start of infusion|Pharmacokinetic parameter: clearance (CL), Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval|Pharmacokinetic parameter: volume of distribution (Vd), Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval|Pharmacokinetic parameter: plasma apparent terminal half-life, Part II: following 9 hour infusion; Part III: following 7 hour infusion|Pharmacodynamic parameter: steady-state glucose infusion-rate (GIR) in Part II, Part II: during the final 60 minutes of the infusion|Number of participants who discontinued study drug due to an adverse event, Part I: 1 day; Parts II and III: 9 days | Secondary: Number of participants with anti-drug antibody (ADA) formation, Up to 30 days following last dose
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| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-11-26
|
| Completion Date: |
2016-07-29
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| Results First Posted: |
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| Last Update Posted: |
2019-01-15
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT02269735
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