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NCT05119894
A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
Phase 1 trial testing Brexpiprazole LAI: Dose 1 in Schizophrenia. Withdrawn.
6 December 2021
Quick facts
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 22 November 2021 |
| Primary completion | 6 December 2021 |
| Estimated completion | 6 December 2021 |
Drugs / interventions tested
- Brexpiprazole LAI: Dose 1 — full drug profile →
- Brexpiprazole LAI: Dose 2
- Brexpiprazole LAI: Dose 3
- Brexpiprazole LAI: Dose 4
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Otsuka Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 64, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-Acting Injectable Antipsychotics-A Review on Formulation and In Vitro Dissolution.
Markowicz-Piasecka M, Kubisiak M, Asendrych-Wicik K, Kołodziejczyk M, et al · · 2023 · cited 27× · PMID 38258037 · DOI 10.3390/pharmaceutics16010028
Verify or expand the search:
- PubMed search for NCT05119894
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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Other Otsuka Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07053891 — LUPKYNIS Drug-use Results Survey · recruiting
- NCT06875986 — REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapi · recruiting
- NCT06036108 — Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia · Phase 1 · completed
- NCT05712746 — Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure. · recruiting
- NCT05687071 — A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05119894 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd.
- Last refreshed: 28 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05119894.
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