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NCT03230916 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT03230916 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 47 participants.
The verdict
NCT03230916, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.
Interventions
- DRUG IMI/REL FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2020-08-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03230916
The ClinicalTrials.gov registry entry for NCT03230916 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 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 IMI/REL FDC is the first listed.
NCT03230916 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03230916 about?
NCT03230916 is a clinical study titled "A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)". This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referre...
What is the current status of trial NCT03230916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2017-11-06. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT03230916?
The interventions under investigation include: IMI/REL FDC (DRUG).
Who is sponsoring clinical trial NCT03230916?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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