Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:16 AM
Study NCT ID:
NCT07314333
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: