A Phase 1 interventional study of ACT541468 and ACT541468 placebo in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Germany. Open to participants aged 24 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-31.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
On Day 1 and Day 2, subjects will EITHER receive: * a single dose of 50 mg ACT-541468 (Treatment A) on Day 1 and a single dose of ACT- 541468 placebo (Treatment B) on Day 2 OR * a single dose of ACT-541468 placebo (Treatment B) on Day 1 and a single dose of 50 mg ACT-541468 (Treatment A) on Day 2.
Drug: ACT541468 · Drug: ACT541468 placebo
From Day 3 to Day 10, subjects will on each day receive: • a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468.
Drug: ACT541468 · Drug: ACT541468 placebo · Drug: Citalopram
50 mg; film-coated tablet for oral use
film-coated tablet for oral use
20 mg; tablet tor oral use; for single- or repeated dosing
Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
Time frame: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10
Number of participants with treatment-emergent AEs from study treatment administration up to EOS
Time frame: AEs from Day 1 to EOS; for up to 15 days post-dose
Number of participants with treatment-emergent SAEs from study treatment administration up to EOS
Time frame: SAEs from Day 1 to EOS; for up to 50 days post-dose
Plan to share: No
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Idorsia Pharmaceuticals Ltd.