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NCT05012670
Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
Phase 1 trial testing [14C]-Paxalisib Capsule in Healthy in 6 participants. Completed in 30 January 2024.
30 March 2023
Quick facts
| Lead sponsor | Kazia Therapeutics Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 18 August 2021 |
| Primary completion | 30 March 2023 |
| Estimated completion | 30 January 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- [14C]-Paxalisib Capsule — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Kazia Therapeutics Limited — full company profile →
Who can join
Adults 30 to 65, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single-centre, open-label, non-randomised study to assess the mass balance recovery, PK, metabolite profile, and metabolite identification of a single oral dose of 14C labelled paxalisib (\[14C\] Paxalisib) in healthy male subjects.
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 NCT05012670
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kazia Therapeutics Limited trials
Trials by the same sponsor.
- NCT05114668 — Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours · Phase 1 · completed
- NCT03522298 — Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma · Phase 2 · completed
- NCT02903771 — Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. · 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 NCT05012670 (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 Kazia Therapeutics Limited
- Last refreshed: 15 March 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/NCT05012670.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing