Trials / Completed
CompletedNCT05012670
Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
An Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Kazia Therapeutics Limited · Industry
- Sex
- Male
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]-Paxalisib Capsule | Each subject will receive a single dose 15 mg (NMT 3.5 MBq), administered orally in the fasted state with with 240 mL water. |
Timeline
- Start date
- 2021-08-18
- Primary completion
- 2023-03-30
- Completion
- 2024-01-30
- First posted
- 2021-08-19
- Last updated
- 2024-03-15
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05012670. Inclusion in this directory is not an endorsement.