Who is sponsoring NCT03189589?

NCT03189589 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03189589?

Interventions in NCT03189589: GSK2269557 500 µg, GSK2269557 750 µg.

What condition does NCT03189589 study?

NCT03189589 studies Pulmonary Disease, Chronic Obstructive.

Is NCT03189589 still recruiting?

NCT03189589 is currently completed. Last updated 19 August 2019.

Are results published for NCT03189589?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-19 · How we verify

NCT03189589

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects

Completed Phase 1 Results posted Last updated 19 August 2019

What this trial tests

Phase 1 trial testing GSK2269557 500 µg in Pulmonary Disease, Chronic Obstructive in 12 participants. Completed in 24 July 2017.

Timeline

15 June 2017

Primary endpoint
24 July 2017

24 July 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	15 June 2017
Primary completion	24 July 2017
Estimated completion	24 July 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

GSK2269557 500 µg — full drug profile →
GSK2269557 750 µg — full drug profile →

Conditions studied

Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean GSK2269557 Plasma Concentration Primary · Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose

Whole blood samples of approximately 2 milliliters were collected for measurement of plasma concentrations of GSK2269557 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population which comprised of all randomized participants in the Safety Population and for whom a PK sample was obtained and analyzed.

Pre-dose

Group	Value	95% CI
GSK2269557 500 mcg	0.0	± 0.00
GSK2269557 750 mcg	0.0	± 0.00

5 minutes post-dose

Group	Value	95% CI
GSK2269557 500 mcg	2175.5	± 843.68
GSK2269557 750 mcg	1871.8	± 985.15

30 minutes post-dose

Group	Value	95% CI
GSK2269557 500 mcg	480.7	± 155.28
GSK2269557 750 mcg	530.7	± 260.82

2 hours post-dose

Group	Value	95% CI
GSK2269557 500 mcg	322.9	± 83.85
GSK2269557 750 mcg	414.6	± 187.63

6 hours post-dose

Group	Value	95% CI
GSK2269557 500 mcg	259.7	± 81.60
GSK2269557 750 mcg	424.0	± 186.51

12 hours post-dose

Group	Value	95% CI
GSK2269557 500 mcg	210.5	± 52.94
GSK2269557 750 mcg	319.5	± 109.94

24 hours post-dose

Group	Value	95% CI
GSK2269557 500 mcg	171.8	± 48.71
GSK2269557 750 mcg	248.9	± 71.92

48 hours post-dose

Group	Value	95% CI
GSK2269557 500 mcg	114.0	± 38.31
GSK2269557 750 mcg	145.2	± 40.54

Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2269557 Primary · Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose

Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.

AUC (0 to t), n=6,6

Group	Value	95% CI
GSK2269557 500 mcg	14032.8	± 5027.09
GSK2269557 750 mcg	18468.7	± 7007.72

AUC (0 to 24), n=6,6

Group	Value	95% CI
GSK2269557 500 mcg	6000.6	± 1646.07
GSK2269557 750 mcg	8497.7	± 3189.43

AUC (0 to inf), n=4,5

Group	Value	95% CI
GSK2269557 500 mcg	19291.7	± 3788.10
GSK2269557 750 mcg	23340.9	± 6395.14

Maximum Observed Plasma Drug Concentration (Cmax) and Concentration at Trough (Ctrough) of GSK2269557 Primary · Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose

Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.

Cmax

Group	Value	95% CI
GSK2269557 500 mcg	2175.5	± 843.68
GSK2269557 750 mcg	1871.8	± 985.15

Ctrough

Group	Value	95% CI
GSK2269557 500 mcg	171.8	± 48.71
GSK2269557 750 mcg	248.9	± 71.92

Time to Maximum Observed Plasma Drug Concentration (Tmax) and Terminal Half-life (t1/2) Primary · Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose

Tmax, n=6,6

Group	Value	95% CI
GSK2269557 500 mcg	0.083	0.08 – 0.10
GSK2269557 750 mcg	0.083	0.07 – 0.083

t1/2, n=4,5

Group	Value	95% CI
GSK2269557 500 mcg	42.7	42 – 48
GSK2269557 750 mcg	38.2	31 – 49

Number of Participants With Vital Signs of Potential Clinical Importance Secondary · Up to Day 2

Vital signs included blood pressure (systolic and diastolic blood pressure) and heart rate measurements and were assessed with the participant in a semi-supine position after 5 minutes rest. The potential clinical concern range values for vital signs were: systolic blood pressure (lower \<85 millimeters of mercury and higher \>160 millimeters of mercury), diastolic blood pressure (lower \<45 millimeters of mercury and higher \>100 millimeters of mercury) and heart rate (lower \<40 beats per minute and higher \>110 beats per minute). Number of participants with vital signs of potential clinical

Group	Value	95% CI
GSK2269557 500 mcg	0
GSK2269557 750 mcg	0

Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance Secondary · Up to Day 2

Twelve-lead ECG was obtained using an ECG machine which automatically measured PR, QRS, QT and corrected QT (QTc) intervals. ECG parameters and their potential clinical importance range values were: absolute QTc interval (lower \>450 milliseconds \[msec\]), absolute PR interval (lower \<110 msec and upper \>220 msec), absolute QRS interval (lower \<75 msec and upper \>110 msec). Number of participants with electrocardiogram (ECG) values of potential clinical importance are presented.

Group	Value	95% CI
GSK2269557 500 mcg	0
GSK2269557 750 mcg	0

Change From Baseline in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) Secondary · Baseline and Day 1

The maximal amount of air forcefully exhaled in 1 second (FEV1) and forced vital capacity (FVC) was measured using a spirometer. Baseline was latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline values from post-dose visit values. Mean change from Baseline in FVC and FEV1 is presented.

FEV1

Group	Value	95% CI
GSK2269557 500 mcg	0.027	± 0.0554
GSK2269557 750 mcg	-0.040	± 0.2060

FVC

Group	Value	95% CI
GSK2269557 500 mcg	0.177	± 0.0836
GSK2269557 750 mcg	0.065	± 0.2780

Number of Participants With Hematology Abnormalities of Potential Clinical Importance Secondary · Up to Day 2

Hematology parameters and their potential clinical concern values were: Hematocrit (high flag: \>0.54 and change from Baseline: decrease of 0.075), hemoglobin (high flag: \>180 grams per Liter and change from Baseline: decrease of 25 grams per Liter), lymphocytes (low flag: \<0.8\*10\^9 cells per Liter), neutrophil count (low flag: \<1.5\*10\^9 cells per Liter), platelet count (low flag: \<100\*10\^9 cells per Liter and high flag: \>550\*10\^9 cells per Liter) and white blood cell count (low flag: \<3\*10\^9 cells per Liter and high flag: \>20\*10\^9 cells per Liter). Number of participants wi

Group	Value	95% CI
GSK2269557 500 mcg	0
GSK2269557 750 mcg	0

Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Secondary · Up to Day 2

Clinical chemistry parameters and their potential clinical concern range values were: calcium (low flag \<2 millimoles/Liter \[mmol/L\] and high flag \>2.75 mmol/L), creatinine (high flag \>44.2 micromoles/Liter increase in change from Baseline), glucose (fasting) (\<3 mmol/L and \>9 mmol/L), potassium (low flag \<3 mmol/L and high flag \>5.5 mmol/L above ULN), sodium (low flag \<130 mmol/L and high flag \>150 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.

Group	Value	95% CI
GSK2269557 500 mcg	0
GSK2269557 750 mcg	0

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Secondary · Up to 12 days post-dose

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any

Group	Value	95% CI
GSK2269557 500 mcg	3
GSK2269557 750 mcg	3

SAE

Group	Value	95% CI
GSK2269557 500 mcg	0
GSK2269557 750 mcg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 days post-dose. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK2269557 500 mcg

Serious: 0/6 (0%)

Deaths: 0/6

GSK2269557 750 mcg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (8 terms — click to expand)

Reaction	System	GSK2269557 500 mcg	GSK2269557 750 mcg
Fatigue	General disorders	—	—
Catheter site inflammation	General disorders	—	—
Headache	Nervous system disorders	—	—
Somnolence	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Limb injury	Injury, poisoning and procedural complications	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03189589 adverse events section.

Sponsor's own description

GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases. This is the first study using a new formulation of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a single dose of GSK2269557. Data derived from this study will inform on the PK profile and systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing 0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study will be carried out in 3 phases, including screening phase, treatment phase and follow-up phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Inhaled RNA Therapeutics for Obstructive Airway Diseases: Recent Advances and Future Prospects.
Xu Y, Thakur A, Zhang Y, Foged C. · · 2021 · cited 24× · PMID 33525500 · DOI 10.3390/pharmaceutics13020177
Kinase inhibitors in the treatment of obstructive pulmonary diseases.
Defnet AE, Hasday JD, Shapiro P. · · 2020 · cited 17× · PMID 32361678 · DOI 10.1016/j.coph.2020.03.005
Safety, Tolerability, and Pharmacokinetics of a New Formulation of Nemiralisib Administered via a Dry Powder Inhaler to Healthy Individuals.
Wilson R, Templeton A, Leemereise C, Eames R, et al · · 2019 · cited 8× · PMID 31076203 · DOI 10.1016/j.clinthera.2019.04.008

Verify or expand the search:

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03189589 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 19 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03189589.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing