A Phase 1 interventional study of Centanafadine in Attention-deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 5 sites in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Treatment
This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
There will be multiple cohorts dosed with open-label centanafadine.
Drug: Centanafadine
Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).
Maximal peak plasma concentration (Cmax)
Time frame: 24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time frame: 24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time frame: 24 hours
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Development & Commercialization, Inc.