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NCT04972227
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Phase 1 trial testing CY6463 in Schizophrenia in 48 participants. Completed in 18 April 2022.
18 April 2022
Quick facts
| Lead sponsor | Tisento Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 10 September 2021 |
| Primary completion | 18 April 2022 |
| Estimated completion | 18 April 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- CY6463 — full drug profile →
- Placebo
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Tisento Therapeutics — full company profile →
Who can join
Adults 18 to 50, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to evaluate the safety and tolerability of CY6463 when administered to participants with stable schizophrenia who are on a stable antipsychotic medication regimen
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04972227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CY6463
Trials testing the same drug.
- NCT04798989 — A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology · Phase 2 · terminated
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
- NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
- NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
Other Tisento Therapeutics trials
Trials by the same sponsor.
- NCT06402123 — A Phase 2b Study of Zagociguat in Patients With MELAS · Phase 2 · active not recruiting
- NCT04798989 — A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology · Phase 2 · terminated
- NCT04475549 — Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Epi · Phase 2 · terminated
- NCT04240158 — IW-6463 Safety Study in Healthy Elderly Subjects · Phase 1 · terminated
- NCT03856827 — A Study of IW-6463 in Healthy Volunteers · Phase 1 · 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 NCT04972227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tisento Therapeutics
- Last refreshed: 13 August 2024
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/NCT04972227.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing