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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEP-380135 + Quinidine Gluconate | Experimental | Participants receive SEP-380135 alone on Day 1, followed by administration of quinidine gluconate beginning on Day 6. On Day 7, SEP-380135 is coadministered with quinidine gluconate. Quinidine gluconate dosing continues from Day 8 to Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-380135 | Drug | Oral capsules. |
| |
| Quinidine Gluconate |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites | Up to Day 11 | |
| Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites | Up to Day 11 | |
| Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites | Up to Day 11 | |
| Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites | Up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 2 months | |
| Number of Participants With Potentially Clinically Significant Changes in Vital Signs | Up to 2 months | |
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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:
Willing to stay in the clinic for the required period (i.e., to be hospitalized for 10 days) and willing to be contacted for the safety follow-up telephone call.
Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the trial.
Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Vince Clinical Research | Overland Park | Kansas | 66212 | United States |
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C016713 | quinidine gluconate |
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| Drug |
Oral extended-release (ER) tablets. |
|
| Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters |
| Up to 2 months |
| Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | Up to 2 months |
| Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations | Up to 2 months |
| Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters | Up to 2 months |
| Number of Participants With Incidence of Suicidal Behavior, Suicidal Ideation and Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 2 months |