Trial Outcomes & Findings for A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis (NCT NCT00464568)
NCT ID: NCT00464568
Last Updated: 2018-08-20
Results Overview
The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4, group A, member 2 (NR4A2), Phosphodiesterase-4A (PDE4A), Regulator of G-protein signalling 1 (RGS1), Serine/threonine protein kinase SNF1 like kinase (SNF1LK). Nasal lavage cytospins were stained with a SNF1LK specific monoclonal antibody by indirect immunofluorescence. Adjusted Geometric Mean and Standard error logs are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Day 1
Results posted on
2018-08-20
Participant Flow
A total of 32 healthy adult females and males aged 18 to 50 years and having a positive history of seasonal allergic rhinitis (SAR) were enrolled. The study was conducted at a single center in Germany from 28-March-2007 to 16-May-2007.
Participants who were positive for grass pollen on radioallergosorbent and skin prick testing were enrolled. Participants underwent Screening 7 to 28 days prior to study start.
Participant milestones
| Measure |
Overall Study
Eligible participants received unit dose of nasal GSK256066 1 microgram (mcg) or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall Study
Eligible participants received unit dose of nasal GSK256066 1 microgram (mcg) or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis
Baseline characteristics by cohort
| Measure |
Overall Study
n=32 Participants
Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
|
|---|---|
|
Age, Continuous
|
35.7 Years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All Subjects population comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4, group A, member 2 (NR4A2), Phosphodiesterase-4A (PDE4A), Regulator of G-protein signalling 1 (RGS1), Serine/threonine protein kinase SNF1 like kinase (SNF1LK). Nasal lavage cytospins were stained with a SNF1LK specific monoclonal antibody by indirect immunofluorescence. Adjusted Geometric Mean and Standard error logs are presented.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
FOSL2
|
10550.0 COPIES/50 nanogram (NG)
Standard Error 0.03
|
15672.4 COPIES/50 nanogram (NG)
Standard Error 0.03
|
16039.4 COPIES/50 nanogram (NG)
Standard Error 0.03
|
17776.4 COPIES/50 nanogram (NG)
Standard Error 0.03
|
16374.4 COPIES/50 nanogram (NG)
Standard Error 0.03
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
IRS2
|
3260.5 COPIES/50 nanogram (NG)
Standard Error 0.05
|
5052.0 COPIES/50 nanogram (NG)
Standard Error 0.05
|
5059.6 COPIES/50 nanogram (NG)
Standard Error 0.05
|
5671.2 COPIES/50 nanogram (NG)
Standard Error 0.05
|
5083.8 COPIES/50 nanogram (NG)
Standard Error 0.05
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
NR4A2
|
703.3 COPIES/50 nanogram (NG)
Standard Error 0.07
|
1081.0 COPIES/50 nanogram (NG)
Standard Error 0.07
|
1316.8 COPIES/50 nanogram (NG)
Standard Error 0.07
|
1522.5 COPIES/50 nanogram (NG)
Standard Error 0.07
|
1427.1 COPIES/50 nanogram (NG)
Standard Error 0.07
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
SNF1LK
|
2502.7 COPIES/50 nanogram (NG)
Standard Error 0.05
|
6810.4 COPIES/50 nanogram (NG)
Standard Error 0.05
|
7608.3 COPIES/50 nanogram (NG)
Standard Error 0.05
|
8205.7 COPIES/50 nanogram (NG)
Standard Error 0.05
|
8317.7 COPIES/50 nanogram (NG)
Standard Error 0.05
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
CREM
|
2625.5 COPIES/50 nanogram (NG)
Standard Error 0.03
|
2987.2 COPIES/50 nanogram (NG)
Standard Error 0.03
|
3134.2 COPIES/50 nanogram (NG)
Standard Error 0.03
|
3162.0 COPIES/50 nanogram (NG)
Standard Error 0.03
|
3727.0 COPIES/50 nanogram (NG)
Standard Error 0.03
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
DUSP1
|
8771.4 COPIES/50 nanogram (NG)
Standard Error 0.04
|
12718.0 COPIES/50 nanogram (NG)
Standard Error 0.04
|
13569.4 COPIES/50 nanogram (NG)
Standard Error 0.04
|
15221.2 COPIES/50 nanogram (NG)
Standard Error 0.04
|
15310.1 COPIES/50 nanogram (NG)
Standard Error 0.04
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
PDE4A
|
43.4 COPIES/50 nanogram (NG)
Standard Error 0.05
|
44.5 COPIES/50 nanogram (NG)
Standard Error 0.05
|
51.3 COPIES/50 nanogram (NG)
Standard Error 0.05
|
51.7 COPIES/50 nanogram (NG)
Standard Error 0.05
|
59.8 COPIES/50 nanogram (NG)
Standard Error 0.05
|
|
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression
RGS1
|
509.5 COPIES/50 nanogram (NG)
Standard Error 0.06
|
542.2 COPIES/50 nanogram (NG)
Standard Error 0.06
|
617.6 COPIES/50 nanogram (NG)
Standard Error 0.06
|
698.4 COPIES/50 nanogram (NG)
Standard Error 0.06
|
697.3 COPIES/50 nanogram (NG)
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
The FEV1 is the volume of air forcefully exhaled in 1 second. The highest FEV1 value amongst the three recorded FEV1 readings was used for all FEV1 calculations. FEV1 was recorded pre-dose and at follow-up.
Outcome measures
| Measure |
Placebo
n=32 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Mean Forced Expiratory Volume in One Second (FEV1)
|
4.073 Liters (L)
Standard Deviation 0.9045
|
4.116 Liters (L)
Standard Deviation 0.8506
|
4.018 Liters (L)
Standard Deviation 0.8564
|
4.151 Liters (L)
Standard Deviation 0.8726
|
4.096 Liters (L)
Standard Deviation 0.8909
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
Vital signs included SBP and DBP. SBP and DBP were measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study Period
DBP
|
70.8 Millimetres of mercury (mmHg)
Standard Deviation 6.06
|
69.4 Millimetres of mercury (mmHg)
Standard Deviation 6.33
|
69.2 Millimetres of mercury (mmHg)
Standard Deviation 6.67
|
70.6 Millimetres of mercury (mmHg)
Standard Deviation 7.24
|
68.9 Millimetres of mercury (mmHg)
Standard Deviation 6.83
|
|
Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study Period
SBP
|
117.0 Millimetres of mercury (mmHg)
Standard Deviation 10.76
|
117.0 Millimetres of mercury (mmHg)
Standard Deviation 10.34
|
113.8 Millimetres of mercury (mmHg)
Standard Deviation 9.51
|
118.9 Millimetres of mercury (mmHg)
Standard Deviation 10.91
|
115.1 Millimetres of mercury (mmHg)
Standard Deviation 9.97
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
Vital signs included heart rate. Heart rate was measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Mean Heart Rate Over Study Period
|
58.8 Beats/minute
Standard Deviation 9.47
|
59.7 Beats/minute
Standard Deviation 9.10
|
57.9 Beats/minute
Standard Deviation 9.16
|
60.5 Beats/minute
Standard Deviation 12.34
|
57.8 Beats/minute
Standard Deviation 10.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to 9 weeksPopulation: All subjects population.
Electrocardiogram variables evaluated included PR interval, QRS duration, QT interval, QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) and RR interval. ECG was performed pre-dose, one hour and four hour post-dose. The ECG measurements were made with the participant in a supine position having rested in this position for at least 10 minutes before each time-point. Baseline was defined as the pre-dose measurement on Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Values
PR Interval, 1 hour post-dose
|
-1.10 Millisecond (msec)
Standard Deviation 6.650
|
-0.87 Millisecond (msec)
Standard Deviation 6.962
|
-0.13 Millisecond (msec)
Standard Deviation 9.157
|
1.73 Millisecond (msec)
Standard Deviation 8.132
|
1.81 Millisecond (msec)
Standard Deviation 8.553
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QRS Duration, 1 hour post-dose
|
-0.77 Millisecond (msec)
Standard Deviation 3.783
|
-0.27 Millisecond (msec)
Standard Deviation 2.449
|
-0.50 Millisecond (msec)
Standard Deviation 3.172
|
-1.40 Millisecond (msec)
Standard Deviation 2.931
|
0.06 Millisecond (msec)
Standard Deviation 4.049
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QRS Duration, 4 hour post-dose
|
-0.97 Millisecond (msec)
Standard Deviation 3.996
|
-0.93 Millisecond (msec)
Standard Deviation 3.005
|
-1.06 Millisecond (msec)
Standard Deviation 3.835
|
-1.40 Millisecond (msec)
Standard Deviation 2.931
|
0.13 Millisecond (msec)
Standard Deviation 4.440
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QT Interval, 1 hour post-dose
|
3.55 Millisecond (msec)
Standard Deviation 10.865
|
11.67 Millisecond (msec)
Standard Deviation 13.996
|
6.38 Millisecond (msec)
Standard Deviation 13.645
|
8.93 Millisecond (msec)
Standard Deviation 12.213
|
4.77 Millisecond (msec)
Standard Deviation 11.851
|
|
Change From Baseline in Electrocardiogram (ECG) Values
RR Interval, 1 hour post-dose
|
15.65 Millisecond (msec)
Standard Deviation 93.021
|
58.51 Millisecond (msec)
Standard Deviation 94.468
|
46.48 Millisecond (msec)
Standard Deviation 72.070
|
30.62 Millisecond (msec)
Standard Deviation 95.905
|
14.37 Millisecond (msec)
Standard Deviation 100.749
|
|
Change From Baseline in Electrocardiogram (ECG) Values
PR Interval, 4 hour post-dose
|
-4.06 Millisecond (msec)
Standard Deviation 7.857
|
-5.87 Millisecond (msec)
Standard Deviation 11.374
|
-3.00 Millisecond (msec)
Standard Deviation 7.379
|
-2.40 Millisecond (msec)
Standard Deviation 10.081
|
-5.74 Millisecond (msec)
Standard Deviation 9.560
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QT Interval, 4 hour post-dose
|
-17.29 Millisecond (msec)
Standard Deviation 16.113
|
-11.40 Millisecond (msec)
Standard Deviation 16.079
|
-13.88 Millisecond (msec)
Standard Deviation 12.638
|
-15.07 Millisecond (msec)
Standard Deviation 21.151
|
-16.52 Millisecond (msec)
Standard Deviation 18.147
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QTcB, 1 hour post-dose
|
0.58 Millisecond (msec)
Standard Deviation 13.393
|
1.67 Millisecond (msec)
Standard Deviation 11.689
|
-2.94 Millisecond (msec)
Standard Deviation 9.277
|
1.23 Millisecond (msec)
Standard Deviation 14.555
|
1.03 Millisecond (msec)
Standard Deviation 14.061
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QTcB, 4 hour post-dose
|
-2.32 Millisecond (msec)
Standard Deviation 14.063
|
0.30 Millisecond (msec)
Standard Deviation 18.646
|
-4.44 Millisecond (msec)
Standard Deviation 13.361
|
-1.27 Millisecond (msec)
Standard Deviation 15.726
|
-2.32 Millisecond (msec)
Standard Deviation 12.621
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QTcF, 1 hour post-dose
|
1.41 Millisecond (msec)
Standard Deviation 9.975
|
4.39 Millisecond (msec)
Standard Deviation 8.874
|
0.40 Millisecond (msec)
Standard Deviation 8.707
|
4.22 Millisecond (msec)
Standard Deviation 10.710
|
2.37 Millisecond (msec)
Standard Deviation 11.237
|
|
Change From Baseline in Electrocardiogram (ECG) Values
QTcF, 4 hour post-dose
|
-7.07 Millisecond (msec)
Standard Deviation 11.240
|
-3.99 Millisecond (msec)
Standard Deviation 13.260
|
-7.27 Millisecond (msec)
Standard Deviation 10.288
|
-5.42 Millisecond (msec)
Standard Deviation 13.281
|
-6.82 Millisecond (msec)
Standard Deviation 10.284
|
|
Change From Baseline in Electrocardiogram (ECG) Values
RR Interval, 4 hour post-dose
|
-77.76 Millisecond (msec)
Standard Deviation 104.801
|
-52.34 Millisecond (msec)
Standard Deviation 136.084
|
-52.06 Millisecond (msec)
Standard Deviation 90.711
|
-73.88 Millisecond (msec)
Standard Deviation 113.590
|
-75.43 Millisecond (msec)
Standard Deviation 101.077
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
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 dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE
|
7 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
Blood samples for hematology were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with hematology of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for white blood cell count (clinical concern range: 3 to 20 giga cells/liter), neutrophils (normal range: 2.1 to 10.0 giga cells/liter), hemoglobin (clinical concern upper value: \>180 grams/liter). Only those parameters for which at least one value of potential clinical concern was reported are summarized.
Outcome measures
| Measure |
Placebo
n=32 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Values of Potential Clinical Concern
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: All subjects population.
Blood samples for clinical chemistry were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with clinical chemistry values of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for total bilirubin levels (clinical concern upper value: \>31 micromole/liter) and inorganic phosphorus level (normal range: 0.7-1.5 millimole/liter).
Outcome measures
| Measure |
Placebo
n=32 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Values of Potential Clinical Concern
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK parameter population comprised of all participants from the PK Concentration population (comprised of all participants from the All Subjects population for whom blood or nasal samples were taken for assaying study drug) for whom PK parameters were available. Only those participants with data available at the indicated time points were analyzed.
The pharmacokinetics (PK) of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the active investigational product provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066. AUC (0-last) was not calculable for any participant at 1 mcg GSK256066 dose.
Outcome measures
| Measure |
Placebo
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=4 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=18 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=29 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066
|
—
|
7.7 Picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 58
|
14.7 Picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 59
|
41.9 Picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 97
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK parameter population. Only those participants with data available at the indicated time points were analyzed.
The PK of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. AUC (0-last) was not calculable in any participant at the 1, 10 or 50 mcg GSK256066 dose.
Outcome measures
| Measure |
Placebo
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=18 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
AUC (0-last) of Active Metabolite GSK614917
|
—
|
—
|
—
|
12.7 pg * hr/mL
Geometric Coefficient of Variation 63.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK Parameter population. Only those participants with data available at the indicated time points were analyzed.
The PK of GSK256066 were assessed in plasma by determining Cmax. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.
Outcome measures
| Measure |
Placebo
n=3 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=10 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=29 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066
|
6.3 Picogram per mililiter (pg/mL)
Geometric Coefficient of Variation 198
|
5.1 Picogram per mililiter (pg/mL)
Geometric Coefficient of Variation 110
|
5.9 Picogram per mililiter (pg/mL)
Geometric Coefficient of Variation 70
|
20.4 Picogram per mililiter (pg/mL)
Geometric Coefficient of Variation 121
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK parameter population. Only those participants with data available at the indicated time points were analyzed.
The PK of GSK614917 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. C max was not calculable for any participant at the 1 mcg GSK256066 dose.
Outcome measures
| Measure |
Placebo
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=3 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=6 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=24 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Cmax of Active Metabolite GSK614917
|
—
|
2.7 pg/mL
Geometric Coefficient of Variation 47.6
|
2.4 pg/mL
Geometric Coefficient of Variation 20.1
|
5.2 pg/mL
Geometric Coefficient of Variation 62.4
|
—
|
SECONDARY outcome
Timeframe: Pre -dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK Parameter population. Only those participants with data available at the indicated time points were analyzed.
The PK of GSK256066 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.
Outcome measures
| Measure |
Placebo
n=3 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=10 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=29 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) and Time to Last Observed Plasma Drug Concentration (Tlast) of GSK256066
Tlast
|
3.000 Hour
Interval 0.25 to 3.98
|
2.000 Hour
Interval 0.52 to 4.0
|
3.020 Hour
Interval 2.0 to 4.37
|
4.000 Hour
Interval 1.03 to 4.08
|
—
|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) and Time to Last Observed Plasma Drug Concentration (Tlast) of GSK256066
Tmax
|
3.000 Hour
Interval 0.25 to 3.98
|
2.000 Hour
Interval 0.5 to 4.0
|
2.000 Hour
Interval 1.0 to 3.03
|
2.000 Hour
Interval 1.0 to 4.05
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1Population: PK parameter population.
The PK of GSK614917 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Tmax and Tlast could not be determined for any participant at the 1 mcg GSK256066 dose.
Outcome measures
| Measure |
Placebo
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=3 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=6 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=24 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Tmax and Tlast of Active Metabolite GSK614917
Tlast
|
—
|
2.000 Hour
Interval 0.52 to 3.98
|
2.510 Hour
Interval 1.97 to 4.0
|
4.000 Hour
Interval 2.98 to 4.08
|
—
|
|
Tmax and Tlast of Active Metabolite GSK614917
Tmax
|
—
|
2.000 Hour
Interval 0.52 to 3.98
|
2.010 Hour
Interval 1.97 to 4.0
|
3.000 Hour
Interval 2.0 to 4.05
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: PK concentration population.
Nasal lavage samples were taken 2 -3 hour post morning dose and analyzed for GSK256066. Quantifiable levels of GSK256066 were observed in nasal lavage samples obtained 2-3 hours post-dose.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Nasal Lavage Concentrations of GSK256066
|
6.460 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 269.6
|
124.700 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 165.1
|
457.370 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 233.5
|
1046.088 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 161.8
|
2226.638 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 161.7
|
SECONDARY outcome
Timeframe: Day 1Population: All subjects population. Only those participants available at the specified time points were analyzed.
Nasal lavage were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal lavage samples were analyzed to explore the effects of GSK256066 on novel protein biomarkers including pVASP. Markers indicative of PDE4 inhibition such as VASP protein levels and phospho157 VASP were also measured in this study, in lavage cells, following positive data in an enabling study which showed increases in such protein levels in participants with allergic rhinitis following a single intranasal dose of salbutamol. Nasal lavage data from earlier studies showed that pVASP157 is the best marker and not pVASP239. pVASP239 was therefore not collected or analyzed as planned.
Outcome measures
| Measure |
Placebo
n=31 Participants
Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
|
GSK256066 1 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 10 mcg
n=32 Participants
Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 50 mcg
n=30 Participants
Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
|
GSK256066 200 mcg
n=31 Participants
Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
|
|---|---|---|---|---|---|
|
Mean Levels of Total Vasodilator Stimulated Phosphoprotein (VASP) Protein, Phosphorylated(Phospho)157 VASP (pVASP) and phospho239 VASP in Lavage Cells
VASP
|
3.5734 Percentage
Standard Deviation 7.5089
|
2.9960 Percentage
Standard Deviation 4.0191
|
3.0920 Percentage
Standard Deviation 4.4718
|
3.6985 Percentage
Standard Deviation 5.2735
|
2.2363 Percentage
Standard Deviation 3.3898
|
|
Mean Levels of Total Vasodilator Stimulated Phosphoprotein (VASP) Protein, Phosphorylated(Phospho)157 VASP (pVASP) and phospho239 VASP in Lavage Cells
pVASP
|
4.4913 Percentage
Standard Deviation 12.4942
|
1.8662 Percentage
Standard Deviation 3.6169
|
2.9963 Percentage
Standard Deviation 4.1263
|
2.6670 Percentage
Standard Deviation 4.9340
|
3.0254 Percentage
Standard Deviation 5.1593
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GSK256066 1 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK256066 10 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK256066 50 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GSK256066 200 mcg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
|
GSK256066 1 mcg
n=30 participants at risk
Participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
|
GSK256066 10 mcg
n=32 participants at risk
Participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
|
GSK256066 50 mcg
n=30 participants at risk
Participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
|
GSK256066 200 mcg
n=31 participants at risk
Participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
6.2%
2/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
10.0%
3/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
12.9%
4/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Infections and infestations
Rhinitis
|
6.5%
2/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
6.5%
2/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.1%
1/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
6.5%
2/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal necrosis
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Eye disorders
Eye pruritus
|
6.5%
2/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Eye disorders
Photophobia
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.1%
1/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
General disorders
Fatigue
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.3%
1/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.1%
1/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Cardiac disorders
Idioventricular rhythm
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Psychiatric disorders
Listless
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
3.1%
1/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
3.2%
1/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/32 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/30 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
0.00%
0/31 • Up to 9 weeks
On-treatment Serious adverse events (SAE) and non-serious adverse events (nSAE) are reported for the All Subjects population which comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER