A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women (NCT07305779) | Clinical Trial Compass
CompletedPhase 1
A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women
United States12 participantsStarted 2025-03-07
Plain-language summary
The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Male or female participants between 18 and 55 years of age (inclusive) at time of consent
✓. Body mass index from 18.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
✓. In good health as determined by:
✓. Medical history
✓. Physical examination
✓. Vital signs
✓. Neurological examination
✓. Electrocardiogram
Exclusion criteria
✕. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
✕. Have had previous exposure to SEP-380135.
✕. Are currently participating in another clinical trial.
✕. Attempted suicide within 12 months prior to screening.
✕. A history of sick sinus syndrome, first-, second-, or third-degree atrioventricular block, myocardial infarction, New York Heart Association Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
What they're measuring
1
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
Timeframe: Up to Day 11
2
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites
Timeframe: Up to Day 11
3
Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites
Timeframe: Up to Day 11
4
Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites
Timeframe: Up to Day 11
Trial details
NCT IDNCT07305779
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.