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NCT03457727 · ClinicalTrials.gov registry record · Phase 1
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03457727 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants.
The verdict
NCT03457727, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations. Part A will support the selection of the formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK) profile of selected formulation from Part A. Danirixin is currently administered with food, therefore the investigation of food effect for the selected formulation could potentially enable dosing without food. Approximately 16 subjects will be included in Part A and approximately 24 subjects will be included in Part B. Both parts will include a screening phase, treatment phase with in-between washout period and a follow-up phase.
Interventions
- DRUG Omeprazole
- DRUG Danirixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2018-07-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03457727
The ClinicalTrials.gov registry entry for NCT03457727 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 2 interventions - of which Omeprazole is the first listed.
NCT03457727 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03457727 about?
NCT03457727 is a clinical study titled "GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects". This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations. Part A will support the selection of the formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK) profile of selected formulation from Par...
What is the current status of trial NCT03457727?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-03-07. Estimated completion is 2018-07-25.
What interventions are being tested in trial NCT03457727?
The interventions under investigation include: Omeprazole (DRUG), Danirixin (DRUG).
Who is sponsoring clinical trial NCT03457727?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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