ICON
Salt Lake City, Utah, 84124, United States
NCT Number: NCT07314333
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral, QD XR capsules.
Other names: EB-1020
Oral tablets.
Other names: Concerta
Oral capsules
Other names: Vynase
Time frame: Baseline, Day 12 or ET
Time frame: Baseline, Day 12 or ET
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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