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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
NCT02691325 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02691325
The ClinicalTrials.gov registry entry for NCT02691325 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02691325 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02691325?
The interventions under investigation include: GSK2269557 ELLIPTA DPI (DRUG), Placebo ELLIPTA DPI (DRUG), Activated charcoal (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02691325?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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