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NCT02691325 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
A Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT02691325: Completed Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT02691325 is a Phase 1 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 22 participants, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02691325, a Phase 1 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts. The aim of Part A and B of the study are to assess the safety, tolerability and pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will investigate the proportion of the systemic exposure that post inhalation is due to the swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C may be run sequentially or in parallel. Part A is a randomized, double blind, placebo controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects. Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10 days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and without ingestion of activated charcoal. ELLIPTA is the registered trademark of GlaxoSmithKline groups of companies.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Conditions Studied
Interventions
- DRUG GSK2269557 ELLIPTA DPI
- DRUG Placebo ELLIPTA DPI
- DRUG Activated charcoal
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-03-14 |
| Est. Completion | 2016-06-05 |
| Phase | Phase 1 |
What the finished NCT02691325 record still lists
NCT02691325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which GSK2269557 ELLIPTA DPI is the first listed.
NCT02691325 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02691325 about?
NCT02691325 is a clinical study titled "Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects". GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts. The aim of Part A and B of ...
What is the current status of trial NCT02691325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2016-03-14. Estimated completion is 2016-06-05.
What conditions does trial NCT02691325 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02691325?
The interventions under investigation include: GSK2269557 ELLIPTA DPI (DRUG), Placebo ELLIPTA DPI (DRUG), Activated charcoal (DRUG).
Who is sponsoring clinical trial NCT02691325?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02691325 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02691325's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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