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NCT02453022 · ClinicalTrials.gov registry record · Phase 1
A 5-Period, Single Dose, Phase 1 Study in Healthy Elderly Subjects to Assess Relative Bioavailability and Food Effect of Two Oral Formulations of GSK1325756 (Free Base vs HBr Salt) and Food Effect on the HBr Formulation When Given With Omeprazole
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02453022 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants.
The verdict
NCT02453022, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The current study will help to increase our understanding of the pharmacokinetics (PK) of danirixin. The primary objective of the study is to estimate the relative bioavailability of danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and tolerability information for oral administration of danrixin HBr tablets in elderly subjects will also be obtained. Secondarily, this study will evaluate effect of food on PK of danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of danirixin HBr. The outcome of this study will contribute to the selection of the most appropriate formulation/dosing regimen for future studies. This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will be done within 3 to 10 days post last dose.
Interventions
- DRUG Danirixin HBr 50 mg IR Tablet
- DRUG Danirixin FB 50 mg IR Tablet
- DRUG Prilosec (omeprazole) 40mg Delayed-Release capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2015-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02453022
The ClinicalTrials.gov registry entry for NCT02453022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 3 interventions - of which Danirixin HBr 50 mg IR Tablet is the first listed.
NCT02453022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02453022 about?
NCT02453022 is a clinical study titled "A 5-Period, Single Dose, Phase 1 Study in Healthy Elderly Subjects to Assess Relative Bioavailability and Food Effect of Two Oral Formulations of GSK1325756 (Free Base vs HBr Salt) and Food Effect on the HBr Formulation When Given With Omeprazole". The current study will help to increase our understanding of the pharmacokinetics (PK) of danirixin. The primary objective of the study is to estimate the relative bioavailability of danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and tolerability information f...
What is the current status of trial NCT02453022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-05-18. Estimated completion is 2015-07-31.
What interventions are being tested in trial NCT02453022?
The interventions under investigation include: Danirixin HBr 50 mg IR Tablet (DRUG), Danirixin FB 50 mg IR Tablet (DRUG), Prilosec (omeprazole) 40mg Delayed-Release capsule (DRUG).
Who is sponsoring clinical trial NCT02453022?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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