New schizophrenia drug put through interaction test in 12 volunteers

NCT ID NCT07305779

Completed Knowledge-focused Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 1 trial enrolled 12 healthy adults to see how a single dose of the experimental schizophrenia drug SEP-380135 interacts with quinidine, a medicine that blocks a key liver enzyme. Researchers measured drug levels in the blood and monitored safety. The goal is to understand how other drugs might affect SEP-380135's breakdown, guiding future dosing in patients.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: SEP-380135 (oral capsule) and quinidine gluconate (oral tablet)
What this could lead to: If successful, this study will help determine safe dosing for SEP-380135 when taken with other medications that affect the same liver enzyme.
What could go wrong: This is a very early, small study in healthy people, not patients. It only looks at drug interactions, not whether SEP-380135 works for schizophrenia. Results may not predict real-world effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY VOLUNTEERS SCHIZOPHRENIA

Contacts and locations

Locations

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

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