Last updated: 11/07/2018 02:53:30
A healthy volunteer study with inhaled GSK573719 and placebo
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers.
Trial description: This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
Timeframe: Various
Secondary outcomes:
Blood and urine levels of study drug
Timeframe: various
Interventions:
Enrollment:
36
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Invest. 2013;33(9):653-64.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
May 2008 to October 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy.
- Male or female 18 to 65 years of age inclusive.
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
- A history of breathing problems (i.e. history of asthmatic symptomatology).
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy.
- Male or female 18 to 65 years of age inclusive.
- Non-childbearing women or women of child bearing potential who agree to use contraception
- Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
- Part 1: may include extensive, intermediate and ultra-rapid metabolizers
- Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype
- Body Mass Index within the range 18 – 30 kg/m2 (inclusive).
- Capable of giving written informed consent
- Normal ECG;
- Normal lung function.
- Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
- 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
Exclusion criteria:
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
- A history of breathing problems (i.e. history of asthmatic symptomatology).
- Abnormal ECG.
- Abnormal blood pressure.
- Abnormal heart rate
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
- A positive test for HIV antibody (if determined by the local SOPs).
- History of high alcohol consumption within three months of the study
- The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, (except for simple analgesics e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John’s Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication
- History of sensitivity to any of the study medications, 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.
- The subject is unable to use the novel dry powder inhaler correctly.
- The subject has a known allergy or hypersensitivity to milk protein or the excipients magnesium stearate and lactose monohydrate.
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-16-10
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
Results for study 110106 can be found on the GSK Clinical Study Register.
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