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FDA ECG Biomarker Study with Pimozide, Clarithromycin, and Cobicistat
NCT05716854Phase 1Completed
- Sponsor
- Food and Drug Administration
- Start
- Mar 2023
- Primary completion
- Jun 2023
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of pimozide, clarithromycin and cobicistat (7 arms), sponsored by Food and Drug Administration. Primary endpoints: Plasma concentration of pimozide and clarithromycin associated with ΔΔQTc prolongation of 10 ms at 24 hours and ΔΔJ-TpeakC between cobicistat and moxifloxacin compared to moxifloxacin at 24 hours. Started Mar 2023; status: completed.
02
Drugs
pimozideclarithromycincobicistat
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