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NCT01406340 · ClinicalTrials.gov registry record · Phase 1
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01406340 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 22 participants.
The verdict
NCT01406340, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent. GSK1278863 will be administered once daily for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15 days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14 and 15 (dialysis and non-dialysis days; Stage 5).
Interventions
- DRUG 5 mg GSK1278863
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-08-30 |
| Est. Completion | 2013-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01406340
The ClinicalTrials.gov registry entry for NCT01406340 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5 mg GSK1278863 is the first listed.
NCT01406340 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01406340 about?
NCT01406340 is a clinical study titled "Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment". This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent. GSK1278863 will be administered once daily for 14 days to normal subjects and ...
What is the current status of trial NCT01406340?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-08-30. Estimated completion is 2013-08-31.
What interventions are being tested in trial NCT01406340?
The interventions under investigation include: 5 mg GSK1278863 (DRUG).
Who is sponsoring clinical trial NCT01406340?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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