A Phase 1 interventional study of GSK369796 and Placebo in Malaria, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
This study will examine safety of single doses of GSK369796 in healthy subjects, along with some test to examine how quickly GSK369796 gets in your blood, and how long it takes your body to get rid of it.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 41 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible, female subjects must have a negative pregnancy test (i.e. serum bhCG test) and be of:
Exclusion Criteria:
After randomization subjects will receive either 5, 25, 100, 250, 500, 1000, 2000 and 3000 mg of GSK3697969 orally . GSK3697969 will be available as 5, 25 and 250 mg capsules.
Drug: GSK369796
After randomization subjects will receive matching placebo of GSK3697969.
Drug: Placebo
Anti-malarial
Placebo matching GSK369796
Safety and tolerability
Time frame: From Day 1 to follow-up visit
Pharmacokinetics
Time frame: Day 1 to Day 4
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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