Blood Levels and Effects of GSK1325756 in Healthy Adult Volunteers Aged 40 to 80 Years Old
This study will invite two groups of volunteers to participate.
The data from one group of volunteers will be used to find out how much study drug, known as GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected to find out if the level of cetain blood cells, known as neutrophils, change significantly after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64 years of age.
The data from the other group of volunteers will be used to find out if taking the study drug, GSK1325756, twice in one day with or without food, makes a difference to the level of study drug in the blood. This group of volunteers will also provide data to find out if any study drug metabolites are present in the bile, a fluid secreted by the liver. This group of volunteers will be aged 65 to 80 years of age.
|Pulmonary Disease, Chronic Obstructive||Drug: GSK1325756 Drug: Sugar Pill||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Basic Science
|Official Title:||A Randomized Cross-over Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Twice Daily Oral Administration of GSK1325756, Compared to Placebo, in Healthy Subjects; and the Pharmacokinetic Profile of Twice Daily Oral Administration of GSK1325756 in Healthy Fed and Fasted Elderly Subjects|
- Pharmacokinetics [ Time Frame: 48 hours ]
- Pharmacodynamics [ Time Frame: 48 hours ]
- Adverse Events [ Time Frame: 48 hours ]
|Study Start Date:||November 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Sugar Pill||Drug: Sugar Pill|
|Experimental: GSK1325756 200 mg||Drug: GSK1325756|
|Experimental: GSK1325756 50 mg||Drug: GSK1325756|
Experimental: GSK1325756 100 mg
Administered to the volunteer in the fasted and fed states.
The current study will be conducted in two parts. In Part A - Cohort 1, healthy fed subjects aged 40 to 64 years (inclusive) will be enrolled to evaluate both the pharmacokinetics and pharmacodynamics of twice daily oral administration of GSK1325756 compared to matching placebo. In Part B - Cohort 2, healthy elderly subjects aged 65 to 80 years (inclusive) will be enrolled to evaluate the pharmacokinetic profile of twice daily oral administration of GSK1325756 for administered under fed and fasted conditions. Parts A and B may be performed in parallel.
The approximate duration of the current study is expected to be between 64 and 74 days. The study will require subjects to complete a screening visit within 30 days, followed by Part A - Cohort 1 enrolment requiring 3 x (3 day treatment period + 7 day washout period) or Part B Cohort 2 enrolment requiring 2 x (3 day treatment period + 7 day washout period). All subjects will complete a follow up visit within seven to 14 days of last dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267006
|GSK Investigational Site|
|London, United Kingdom, NW10 7EW|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|