Last reviewed · How we verify
NCT03856827
A Study of IW-6463 in Healthy Volunteers
Phase 1 trial testing IW-6463 in Other in 110 participants. Completed in 22 October 2019.
22 October 2019
Quick facts
| Lead sponsor | Tisento Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 110 |
| Start date | 6 February 2019 |
| Primary completion | 22 October 2019 |
| Estimated completion | 22 October 2019 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- IW-6463 — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Other — all drugs for Other →
Sponsor
Tisento Therapeutics — full company profile →
Who can join
Eligibility, any sex, with Other. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
First-in-human trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of zagociguat (CY6463), a CNS-penetrant soluble guanylyl cyclase stimulator.
van Kraaij SJW, Gal P, Borghans LGJM, Klaassen ES, et al · · 2023 · cited 12× · PMID 37118895 · DOI 10.1111/cts.13537 -
15th Conference Clinical Trials Alzheimer’s Disease, November 29–December 2, 2022, San Francisco, CA, USA: Posters (Clinical Trial Alzheimer’s Disease)
· 2022
Verify or expand the search:
- PubMed search for NCT03856827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IW-6463
Trials testing the same drug.
- NCT04240158 — IW-6463 Safety Study in Healthy Elderly Subjects · Phase 1 · terminated
Other recruiting trials for Other
Currently open trials in the same condition.
- NCT06904391 — Education & Mentorship of Advanced Practice Providers to Increase Community-based Research Within the NCORP Network, COA · NA · recruiting
- NCT00840047 — Methionine PET/CT Studies In Patients With Cancer · Phase 2 · active not 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
- NCT04972227 — Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia · Phase 1 · completed
- 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
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 NCT03856827 (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 Tisento Therapeutics
- Last refreshed: 16 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/NCT03856827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing