NCT07314333

A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.

Detailed description

This is a single dose crossover study. Participants in each arm will receive 3 treatments in a 3 -sequence, 3-period, crossover design. In each arm, participants will be randomized to 1 of 3 treatment sequences: Sequence 1: ABC, Sequence 2: BCA, or Sequence 3: CAB. Here's what each treatment incudes: * Treatment A - centanafadine alone in both Arms 1 and 2. * Treatment B - methylphenidate alone in Arm 1 and lisdexamfetamine alone in Arm 2. * Treatment C - centanafadine combined with methylphenidate in Arm 1, and centanafadine combined with lisdexamfetamine in Arm 2. The duration of trial participation for each participant will be approximately 44 days, and the overall trial duration is expected to be approximately 3 months.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Centanafadine	Oral, QD XR capsules.
DRUG	Methylphenidate	Oral tablets.
DRUG	Lisdexamfetamine	Oral capsules

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-04-03
• Completion: 2026-04-03
• First posted: 2026-01-02
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study