A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
Phase 1
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: 100mcgDrug: PlaceboDrug: 500mcgDrug: 1000mcg
- Registration Number
- NCT00803673
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active 100mcg 100mcg 719 Placebo Placebo Placebo '719 Active 2 500mcg 500mcg '719 Active 3 1000mcg 1000mcg '719
- Primary Outcome Measures
Name Time Method General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests Various
- Secondary Outcome Measures
Name Time Method Blood and urine levels of study drug various
Trial Locations
- Locations (1)
GSK Investigational Site
🇧🇪Antwerpen, Belgium