A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07305779
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SEP-380135 — DRUG
    Oral capsules.
  • Quinidine Gluconate — DRUG
    Oral extended-release (ER) tablets.

Study Details

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.

Key Dates

Start date
Mar 7, 2025
Status verified
Nov 2025
Primary completion
May 3, 2025
Completion
May 3, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SEP-380135 + Quinidine Gluconate
    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.

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites [ Time Frame: Up to Day 11 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Vince Clinical ResearchOverland ParkKansas66212-

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