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NCT02011490 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02011490 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 33 participants.
The verdict
NCT02011490, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with normal renal function. The study consists of two parts. In Part 1, participants with renal insufficiency and healthy participants will be administered study drug by IV bolus injection into a peripheral vein. In Part 2, participants with renal insufficiency and healthy participants will be administered study drug as an IV bolus into a peripheral vein, through an IV catheter connected to IV tubing with injection port. Subjects who participate in Part 1 of study may be enrolled in Part 2, which would reduce the overall number of participants enrolled for the study.
Interventions
- DRUG sugammadex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-12-11 |
| Est. Completion | 2014-06-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02011490
The ClinicalTrials.gov registry entry for NCT02011490 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sugammadex is the first listed.
NCT02011490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02011490 about?
NCT02011490 is a clinical study titled "Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)". The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with normal renal function. The study consists of two parts. In Part 1, participa...
What is the current status of trial NCT02011490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-12-11. Estimated completion is 2014-06-06.
What interventions are being tested in trial NCT02011490?
The interventions under investigation include: sugammadex (DRUG).
Who is sponsoring clinical trial NCT02011490?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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