CTN XR (TBM)
DrugOral capsules
Other names: EB-1020
NCT Number: NCT07253441
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
ICON Lenexa, Lenexa, Kansas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Oral capsules
Other names: EB-1020
Oral tablets
Other names: EB-1020
Oral capsules
Other names: EB-1020
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Up to Day 11
Time frame: Up to Day 11
Time frame: 24 Hours postdose up to Day 10
Time frame: Up to Day 11
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: 24 Hours Postdose up to Day 4; Cohorts 3 and 4: 24 Hours Postdose up to Day 10
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Time frame: Up to Day 11
Time frame: Up to Day 11
Time frame: Cohorts 1 and 2: Up to Day 11; Cohorts 3, 4, and 5: Up to Day 17
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
A Multiple-arm, Phase 1, Open-label Trial to Determine Dose Strength Equivalence and Effect of Food on To-Be-Marketed Centanafadine QD XR Capsules, Bioequivalence Between Clinical and To-Be-Marketed QD XR Capsules and Relative Bioavailability of To-Be-Marketed QD XR Capsules to SR Tablets 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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