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Trial details imported from ClinicalTrials.gov
Ethics application status
Single Dose Study of GSK1440115 in Patients With Asthma
A Phase 1, Randomized, Placebo Controlled, Crossover Study to Evaluate the Efficacy of GSK1440115 After a Single Oral Dose in Patients With Asthma
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - 1440115
Treatment: Drugs - Placebo
Experimental: Active drug -
Placebo Comparator: Placebo -
Treatment: Drugs: 1440115
Single dose of either 750 mg or 500 mg administered as 250 mg tablets.
Treatment: Drugs: Placebo
Single dose of matching placebo tablets
Intervention code 
Comparator / control treatment
Secondary outcome 
Change from baseline in FEV1
1, 2, 3, 4, 5, 6, and 7 hours post dose
Key inclusion criteria
1. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
2. Male or female between 18 and 65 years of age, inclusive, at the time of signing
3. Male patients with a female partner of childbearing potential must have had a prior
vasectomy or agree to use adequate contraception from the time of the first dose of
study drug until three months after the last dose of study drug.
4. A female patient is eligible to participate if she is of:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant)
defined as pre-menopausal females with a documented tubal ligation or
hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
[in questionable cases a blood sample with simultaneous follicle stimulating
hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is
confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal
status is in doubt will be required to use one of the contraception methods
defined in the protocol if they wish to continue their HRT during the study.
Otherwise, they must discontinue HRT to allow confirmation of post-menopausal
status prior to study enrolment. For most forms of HRT, at least two to four
weeks will elapse between the cessation of therapy and the blood draw; this
interval depends on the type and dosage of HRT. Following confirmation of their
post-menopausal status, they can resume use of HRT during the study without use
of a contraceptive method.
2. Child-bearing potential, has a negative serum pregnancy test during the Screening
Period, and agrees to use adequate contraception from Screening until four weeks
after the last dose of study drug.
5. BMI within the range of 19-32 kg/m2 (inclusive).
6. Documented history of bronchial asthma that is British Thoracic Society guideline step
1-3, diagnosed at least 3 months prior to the Screening visit.
a. Patient should be on a fixed regimen for at least 4 weeks prior to Screening. The
following asthma medications are permitted: i. Inhaled corticosteroid (ICS) per day
use: <=800mcg of Beclomethasone Dipropionate or budesonide, 320mcg ciclesonide or
500mcg of Fluticasone propionate - or equivalent doses.
ii. Intermittent short-acting inhaled beta-2 agonist therapy (SABA). A minimum of 8
hours washout from SABA is required prior to Screening or study methacholine challenge
tests or FEV1 assessments.
iii. Long-acting inhaled beta-2 agonist (LABA) therapy is not permitted during the
study. If deemed appropriate by the investigator, patients usually managed with LABA
can be switched to SABA in order to comply with requirements for washout. A minimum of
24 hour washout after last dose of LABA is required prior to Screening methacholine
challenge tests or FEV1 assessments.
iv. Therapy with montelukast is allowed provided that administration is separated by
at least 12 hours from study drug dosing (see Section 9).
7. Best FEV1 of >70% predicted normal value during Screening.
8. Hyper-responsive to methacholine such that a baseline methacholine PC20 is <= 4 mg/mL.
9. Increase in PC20 of at least 2 dilutions compared to baseline in the presence of
inhaled beta-agonist in response to a methacholine challenge.
10. Patients who are currently non-smokers or who have not used any inhaled tobacco
products in the previous 6 months prior to first dose of study drug.
11. Average QTcF < 450 msec; or QTc < 480 msec in patients with Bundle Branch Block.
12. AST and ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of Screening.
2. A positive test for HIV antibody.
3. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
4. A positive pre-study drug/alcohol screen.
5. History of regular alcohol consumption within 6 months of the study defined as:
History of regular alcohol intake (average weekly intake of > 21 units males or >14
units females - One unit is equivalent to 270 mL of full strength beer, 470 mL of
light beer, 30 mL of spirits and 100 mL of wine.
6. History of chronic medical disease that in the investigators opinion may affect the
outcome of the study - including interpretation of safety data. This may include, but
is not limited to, malignancy, cardiovascular, hepatic, renal, hematological,
neurological, thyroid disease, endocrine disease, or, other pulmonary diseases.
Examples of specific exclusions include:
- History of heart attack or stroke within past 3 months.
- Presence of known aortic aneurysm.
- COPD, pulmonary fibrosis, or bronchiectasis
- Peptic ulcer disease.
- Urinary tract obstruction.
7. Clinically significant laboratory abnormalities at Screening.
8. History of uncontrolled hypertension or persistent SBP>140 mmHg or DBP >90mmHg at
9. History of life-threatening asthma (asthma episode requiring intubation and/or
associated with hypercapnea, respiratory arrest or hypoxic seizure) OR the following:
- Respiratory tract infection and/or asthma exacerbation within 4 weeks prior to
the first dose of study drug.
- Asthma exacerbation requiring hospitalization within 3 months prior to Screening.
- Administration of systemic steroids within 4 weeks of Screening.
10. Intake of an investigational product within either 30 days or 5 half lives (whichever
is longer) prior to first dose of study drug.
11. History of sensitivity to any of the study drugs, or components thereof or a history
of drug or other allergy that, in the opinion of the investigator or GSK Medical
Monitor, contraindicates their participation.
12. Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
13. Lactating females.
14. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or
nicotine-containing products within 6 months prior to Screening.
15. Current use of a prohibited medication or requires use of a prohibited medication
during study participation.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Investigational Site - New South Wales
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
The purpose of this study is to assess bronchodilator effect after single dose administration
of GSK1440115 in a population of mild to moderate asthmatic patients.
Trial related presentations / publications