At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Sponsor Un-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat, Ascending Doses of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients
In Brief
A Phase 2 clinical trial evaluating GSK2798745 solution, GSK2798745 suspension, and 4 other interventions for Oedema, Pulmonary. Completed, enrolled 61 participants across 2 sites.
Detailed Summary
This study is the first administration of GSK2798745 in humans. This will be a sponsor un-blinded, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2798745, given as single and repeat oral doses to healthy subjects and stable heart failure (HF) subjects. Approximately 28 healthy subjects will be enrolled in the study cohorts (Cohort 1-3) involving single and repeat dose escalations of GSK2798745, while up to 24 stable heart failure subjects will be enrolled in Cohort 4 involving single and repeat dose administration of GSK2798745, with the dose selected based on data from healthy subject cohorts. This would be followed by enrollment of up to 8 subjects with heart failure in Cohort 5 involving repeat dose administration of GSK2798745. The study duration, including screening and follow-up, is not expected to exceed 17 weeks for subjects in the study (in any cohort).
Study Details
Timeline
Interventions
Clear, colourless GSK2798745 (0.1 to 0.4mg) solution in aqueous citrate buffer with 4% captisol
Aqueous suspension of GSK2798745 (\>=0.5 mg)
White Opaque granule filled capsules of GSK2798745 (\>=0.5 mg)
Clear, colourless solution of aqueous citrate buffer with 4% captisol
Visually matching aqueous suspension of hypromellose acetate succinate powder
Matching white opaque placebo blend filled capsule