A Phase 1 interventional study of SB- 773812 60 mg and SB- 773812 120 mg in Schizophrenia, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
In treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram \[mg\] of SB-773812) and one placebo tablet. Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets . There will be a wash-out period of 20 days between.
Drug: SB- 773812 60 mg · Drug: SB- 773812 120 mg · Drug: Placebo
In treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets. Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet. There will be a wash-out period of 20 days between.
Drug: SB- 773812 60 mg · Drug: SB- 773812 120 mg · Drug: Placebo
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
Also known as: 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.
Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions.
Time frame: 336 hrs post SB773812 dosing
Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions.
Time frame: 336 hours post SB-773812 dosing
Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose.
Time frame: 7-14days after last dose
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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