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NCT02201303 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Danirixin (GSK1325756) Inhibition of CD11b Cell Surface Expression
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02201303: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02201303 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201303, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is to determine danirixin (GSK1325756) concentrations required to inhibit neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected children \<2 years and healthy adults. The study will evaluate differences in neutrophil activation between RSV-infected children \<2 years and healthy adults with escalating concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited by danirixin. This study will guide dose prediction to inhibit specific percentages of neutrophils in future pediatric RSV-infection studies. This single-center, in vitro study will consist of 2 parts. Approximately 24 subjects will be enrolled, including 12 healthy adults and 12 RSV-infected children \<2 years.
Primary Outcome
Blood (1.5 milliliter \[mL\]) will be collected from a peripheral vein via indwelling catheter or direct venepuncture. Escalating concentrations of danirixin (0.03-100 micromoles) will be added to whole blood in vitro with a fixed concentration of CXCL1 to determine inhibition of Cluster of Differentiation 11b (CD11b) expression on peripheral blood neutrophils analyzed by Fluorescence-Activated Cell sorting (FACs).
Interventions
- DRUG Danirixin
- OTHER CXCL1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-01-13 |
| Est. Completion | 2015-07-02 |
| Phase | Phase 1 |
What the finished NCT02201303 record still lists
NCT02201303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Danirixin is the first listed.
NCT02201303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201303 about?
NCT02201303 is a clinical study titled "Evaluation of Danirixin (GSK1325756) Inhibition of CD11b Cell Surface Expression". This study is to determine danirixin (GSK1325756) concentrations required to inhibit neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected children \<2 years and healthy adults. The study will evaluate differences in neutrophil activation between RSV-infected childr...
What is the current status of trial NCT02201303?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-01-13. Estimated completion is 2015-07-02.
What interventions are being tested in trial NCT02201303?
The interventions under investigation include: Danirixin (DRUG), CXCL1 (OTHER).
Who is sponsoring clinical trial NCT02201303?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02201303's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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