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-Paxalisib

Phase 1

Healthy | Small molecule | Other |Kazia Therapeutics Limited|Last Updated: Mar 15, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
ORPHAN_DRUGFAST_TRACKRARE_PEDIATRIC_DISEASE
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05012670Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male SubjectsPHASE1 COMPLETED 6 — — Aug 18, 2021Jan 30, 2024Mar 15, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])-Paxalisib
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Mass balance recovery of total radioactivity (TR) in all excreta (urine and faeces): CumAe (amount excreted) and Cum%Ae

To provide plasma samples for metabolite profiling and structural identification
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites

To provide urine samples for metabolite profiling and structural identification
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Collection of urine samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites

To provide faecal samples for metabolite profiling and structural identification
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Collection of faecal samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites

Secondary Endpoints
To determine the routes and rates of elimination of [14C]-Paxalisib
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To identify the chemical structure of each metabolite accounting for more than 10% (in plasma) of circulating TR or metabolites in excreta (urine and faeces) that account for more than 10% of the administered radioactive dose
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Cmax pharmacokinetic (PK) parameter of paxalisib following administration of [14C] Paxalisib
Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-Paxalisib CapsuleEXPERIMENTALSubjects will be dosed on the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects will remain resident in the clinical unit until 168 h post dose (Day 8) and this may be extended up to a maximum of 48 h (i.e., up to Day 10).
Interventions
NameTypeDescription
[14C]-Paxalisib CapsuleDRUGEach subject will receive a single dose 15 mg (NMT 3.5 MBq), administered orally in the fasted state with with 240 mL water.
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males. 2. Aged 30 to 65 years inclusive at the time of signing informed consent. 3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening. 4. Must be willing and able to communicate and participate in the whole study. 5. Must have regular bowel movement...

Countries:United Kingdom
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