Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Muscarinic Receptor Antagonist,, intravenous infusion,, pharmacokinetics, healthy subjects,, safety,, tolerability,, Anticholinergic,, oral dosing,
Brief summary
GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
Interventions
DRUGGSK233705
GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects; * Between the ages of 18-55 years, inclusive * Body mass index within the range 18.0 to 30.0 kg/m2. * Non-smokers * Adequate venous access for intermittent cannulation * 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 in the following: at the screening medical assessment * A mean QTc(B) value at screening \>450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements * A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening. * A mean heart rate outside the range of 40-90 bpm at screening. * History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening. * 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, including herbal remedies such as St John's Wort. * The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study. * The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing. * The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose, | out to 8 hours post dose |
| measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and | out to 24 hours |
| review of adverse events ongoing through out study. | through out study. |
Secondary
| Measure | Time frame |
|---|---|
| Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose. | out to 48 hours post dose. |
Countries
United Kingdom
Outcome results
None listed