Last reviewed · How we verify
NCT06195319
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects
Phase 1 trial testing Simufilam in Absorption in 8 participants. Completed in 27 March 2024.
27 March 2024
Quick facts
| Lead sponsor | Cassava Sciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 8 |
| Start date | 7 February 2024 |
| Primary completion | 27 March 2024 |
| Estimated completion | 27 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Simufilam — full drug profile →
Conditions studied
- Absorption — all drugs for Absorption →
- Metabolism — all drugs for Metabolism →
- Excretion — all drugs for Excretion →
Sponsor
Cassava Sciences, Inc. — full company profile →
Who can join
Adults 18 to 55, male only, with Absorption or Metabolism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the absorption, metabolism, and excretion of \[14C\]-simufilam in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi) \[14C\]-simufilam.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The potential of ARL4C and its-mediated genes in atherosclerosis and agent development.
Liu D, Wang J, Zhang S, Jiang H, et al · · 2025 · PMID 40176913 · DOI 10.3389/fphar.2025.1513340
Verify or expand the search:
- PubMed search for NCT06195319
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Simufilam
Trials testing the same drug.
- NCT06390410 — A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function · Phase 1 · completed
- NCT05575076 — Open-label Extension for Phase 3 Clinical Trials of Simufilam · Phase 3 · terminated
- NCT05026177 — Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease · Phase 3 · terminated
- NCT04994483 — Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease · Phase 3 · completed
Other recruiting trials for Absorption
Currently open trials in the same condition.
- NCT07138326 — Impact on the Absorption of Drugs in Ostomy Patients · recruiting
Other Cassava Sciences, Inc. trials
Trials by the same sponsor.
- NCT06390410 — A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function · Phase 1 · completed
- NCT05575076 — Open-label Extension for Phase 3 Clinical Trials of Simufilam · Phase 3 · terminated
- NCT05352763 — Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease · Phase 2 · terminated
- NCT05026177 — Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease · Phase 3 · terminated
- NCT04994483 — Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease · 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 NCT06195319 (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 Cassava Sciences, Inc.
- Last refreshed: 20 March 2025
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/NCT06195319.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing