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NCT02169583 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02169583 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 24 participants.
The verdict
NCT02169583, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This will be the first time GSK1325756 Solution for Infusion formulation that has been administered to humans. Prior studies have been performed with oral GSK1325756. The primary objectives of this study are to obtain information on the safety, tolerability, and pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of GSK1325756 in healthy subjects. In Part A, single, escalating doses will be given in the same cohort of subjects after a seven day washout. In addition, the study will evaluate the absolute bioavailability of a single dose of the current oral tablet formulation as compared to the IV formulation in Part A. In Part B, twice daily (BID) intravenous dose administration will be given for 5 days (9 total doses) in two separate cohorts of subjects. Data from this study will provide understanding of the safety, tolerability, and PK of intravenously administered GSK1325756 twice daily to guide dose selection in future clinical studies in patients with viral respiratory tract infections
Interventions
- DRUG GSK1325756 Solution
- DRUG GSK1325756 Solution Matching Placebo
- DRUG GSK1325756 Tablet
- DRUG GSK1325756 Tablet Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-06-12 |
| Est. Completion | 2014-08-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02169583
The ClinicalTrials.gov registry entry for NCT02169583 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 4 interventions - of which GSK1325756 Solution is the first listed.
NCT02169583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02169583 about?
NCT02169583 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects". This will be the first time GSK1325756 Solution for Infusion formulation that has been administered to humans. Prior studies have been performed with oral GSK1325756. The primary objectives of this study are to obtain information on the safety, tolerability, and pharmacokinetics (PK) of single and t...
What is the current status of trial NCT02169583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-06-12. Estimated completion is 2014-08-28.
What interventions are being tested in trial NCT02169583?
The interventions under investigation include: GSK1325756 Solution (DRUG), GSK1325756 Solution Matching Placebo (DRUG), GSK1325756 Tablet (DRUG), GSK1325756 Tablet Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT02169583?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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