Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
Status:
Completed
Trial end date:
2015-07-03
Target enrollment:
Participant gender:
Summary
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK]
Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study
investigating the PK profile of four different doses of GSK2981710. Eight subjects will
receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning
and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each
period. Each subject will complete a total of four dosing sessions and 4 days of PK
assessments in 2 weeks. The Part 1 PK data will be used for dose selection and
pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an
additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to
increase confidence. A subject's total participation in Part 1 of the study will last a
maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may
be screened for eligibility and enrolled for Part 2.
Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover
design with 14-day treatment periods investigating the efficacy (cognitive performance) and
tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected
from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments
(6-8 days before each Treatment period) and two 14-day treatment periods separated by a
minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80
subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be
performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each
treatment period), post-dose on the Day 1 of each treatment period to assess acute effects
and on Day 15 of each treatment period (which is the day after the final dose) to assess
chronic effects. A subject's total participation in Part 2 of the study will last
approximately up to 12 weeks including screening.