GSK Investigational Site
London, NW10 7NS, United Kingdom
NCT Number: NCT00500201
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
London, NW10 7NS, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
Other names: SB- 773812
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
Placebo tablets will be administered orally by subjects.
Time frame: 336 hrs post SB773812 dosing
Time frame: 336 hours post SB-773812 dosing
Time frame: 7-14days after last dose
GlaxoSmithKline
Industry
A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
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