Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
succinate, anti-muscarinic, b-agonist
Brief summary
Salt Bridging study for GSK961081
Interventions
DRUGGSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Sponsors
GlaxoSmithKline
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males or female aged between 18 and 50 years. * Body mass index within the range 19-29.9 kilograms/metre2 * Forced Expiratory Volume in 1 second (FEV1) \>80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \> 0.7 * Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.
Exclusion criteria
* Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject * History of respiratory disease * Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening \>450msec on an individual ECG or a PR interval outside the range 120-210 msec * Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. * Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study * Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort. * Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months * Infected with the Hepatitis B, Hepatitis C, or HIV virus * Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 at intervals | during the 10 week study |
| Cardiac monitoring at intervals | during the 10 week study |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of GSK961081 at intervals | during the 10 week study |
| PK parameters at intervals | during the 10week study |
Countries
United Kingdom
Outcome results
None listed