A Phase 1 interventional study of SEP-228432 and SEP-228432 in Healthy, sponsored by Sumitomo Pharma America, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-09.
Sponsored by Sumitomo Pharma America, Inc. · Phase 1, Interventional, and Diagnostic
This is an open-label study investigating the relationship between SEP-228432 and SEP-228431 (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT occupancy, both measured by SPECT imaging.
This is an open-label study investigating the relationship between SEP-228432 and SEP-228431 (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT occupancy, both measured by SPECT imaging using [123I]-2β-carbomethoxy-3β-(4-iodophenyl) tropane ([123I] β -CIT). Up to 3 sequential cohorts of 8 subjects each will have multiple dose administrations of SEP-228432. The target dose for the first cohort will be 200 mg. Dose selection for the remaining cohorts will be based on preliminary review of all available relevant data from prior dosing cohort(s).
Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days; followed by (steady state) at a dose of 200 mg orally once per day for 5 days.
Drug: SEP-228432
Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days.
Drug: SEP-228432
Subjects will receive 40 mg of SEP-228432 (titration) 40 mg of SEP 228432 orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days.
Drug: SEP-228432
40 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days
40 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days
SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
Time frame: Day 8 and 9
Incidence of treatment-emergent adverse events (TEAEs).
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Up to Day 16
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Sumitomo Pharma America, Inc.