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Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects

NCT05012670 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-15

No results posted yet for this study

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

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Kazia Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Philip Evans, MBChB, MRCS · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2023-03-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012670 on ClinicalTrials.gov