Last updated: 11/04/2018 04:28:08
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort parallel-group study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GSK573719 administered as singledoses (750 μg and 1000 μg) and repeat doses over 14 days (250 μg–1000 μg once-daily) of GSK573719 in healthy male and female subjects.
Trial description: GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, Holter and Lead II ECG monitoring, lung function and clinical laboratory safety tests throughout the study
Timeframe: throughout the study
Secondary outcomes:
- Ambulatory blood pressure for repeat dosing - 24hr Holter monitoring for repeat dosing - Plasma and urine concentrations of GSK573719 and derived pharmacokinetic parameters
Timeframe: throughout the study
Interventions:
Drug: GSK573719
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cahn A, Tal-Singer R, Pouliquen IJ, Mehta R, Preece A, Hardes K, Crater G, Deans A . Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies.. Clin Drug Invest. 2013;33(7):477.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
May 2007 to September 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
- Aged between 18-55 years
- Any clinically important abnormality identified at the screening medical assessment
- A history of breathing problems
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
- Aged between 18-55 years
- Non-smokers
- Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
- A signed and dated written informed consent is obtained from the subject
- The subject is capable of giving informed consent
- Available to complete the study
- Subject has a BMI within the range 18.0-30.0kg/m2 inclusive
Exclusion criteria:
- Any clinically important abnormality identified at the screening medical assessment
- A history of breathing problems
- A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
- A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
- A mean heart rate outside the range 40-90 bpm at screening
- History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
- Subjects with a 2D6 poor metabolizer genotype (Caucasian)
- The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
- The subject is currently taking regular (or course of) medication, whether prescribed or not
- The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
- The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
- The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
- The subject has a positive pre-study drug screen
- The subject has a positive pre-study alcohol screen
- The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
- The subject is unable to use the DISKUS
- The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
- The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
- Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-18-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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