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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
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.
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
ICON
Salt Lake City, Utah, United States
Start Date
February 5, 2026
Primary Completion Date
April 3, 2026
Completion Date
April 3, 2026
Last Updated
March 6, 2026
42
ESTIMATED participants
Centanafadine
DRUG
Methylphenidate
DRUG
Lisdexamfetamine
DRUG
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
NCT07478458
NCT07465081
NCT07189442
Data Source & Attribution
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