HealthyPhase 1NCT05012670

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

A Phase 1 study testing [14C]-Paxalisib Capsule in people with Healthy, run by Kazia Therapeutics Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: [14C]-Paxalisib Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited Kingdom
Study dates: 18 Aug 2021to 30 Jan 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males.
Aged 30 to 65 years inclusive at the time of signing informed consent.
Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
Must be willing and able to communicate and participate in the whole study.
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day).
Must provide written informed consent.
Must agree to adhere to the contraception requirements defined in study protocol.

Who cannot join

Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
Subjects who are, or are immediate family members of, a study site or sponsor employee.
Evidence of current SARS-CoV-2 infection.
History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
A confirmed positive alcohol breath test at screening or admission.

Show all 29Show fewer

Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
Subjects with pregnant or lactating partners.
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
Subjects who have been administered IMP in an ADME study in the last 12 months.
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the investigator (laboratory parameters are listed in study protocol).
Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in study protocol)
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody results
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory disease, neurological, or psychiatric disorder, as judged by the investigator.
History of clinically significant GI disease, especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn's Disease, or Irritable Bowel Syndrome.
Any history of pre-diabetes, diabetes mellitus (any type), or hyperglycaemia. At screening, fasting blood glucose and HbA1c must be within the normal range.
History or presence of significant dermatological disorders or skin rashes, as judged by the investigator.
Subject had a QTcF of >450 msec based on ECG at screening or at pre dose, or a history of additional risk factors for Torsades de Pointe (e.g., hypokalaemia, hypomagnesia, a family history of long QT syndrome).
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) within 14 days before IMP administration (see Section 11.4). COVID-19 vaccines are accepted concomitant medications, except for within 72 h of dosing. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
Subjects who have had a COVID-19 vaccine within 72 h (3 days) before IMP administration.
History of GI surgery (with the exception of appendectomy unless it was performed within the previous 12 months).
Acute diarrhoea or constipation in the 7 days before the predicted Day 1. If screening occurs >7 days before the Day 1, this criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: 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

Conditions: Healthy
Being tested: [14C]-Paxalisib Capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]-Paxalisib CapsuleDrug
Also called Phosphoinositide 3-kinase (PI3K) Inhibitor
Each subject will receive a single dose 15 mg (NMT 3.5 MBq), administered orally in the fasted state with with 240 mL water.

Study groups in NCT05012670
Study group	Role	What they receive
[14C]-Paxalisib Capsule	Experimental	Subjects 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). Receives: Drug: [14C]-Paxalisib Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])-Paxalisib
Mass balance recovery of total radioactivity (TR) in all excreta (urine and faeces): CumAe (amount excreted) and Cum%Ae
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide plasma samples for metabolite profiling and structural identification
Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide urine samples for metabolite profiling and structural identification
Collection of urine samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide faecal samples for metabolite profiling and structural identification
Collection of faecal samples for metabolite profiling, structural identification, and quantification analysis of paxalisib metabolites
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Secondary outcomes (18)

To determine the routes and rates of elimination of [14C]-Paxalisib
Calculation of Ae, %Ae, CumAe, and Cum%Ae for TR by interval in urine and faeces
Measured: 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
Identification of the chemical structure of each paxalisib metabolite accounting for more than 10% by area under the curve (AUC) of circulating TR in plasma to identify major metabolites, and identification of each metabolite in excreta (urine and faeces) that accounts for more than 10% of the administered radioactive dose
Measured: 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
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of paxalisib in plasma including but not limited to Cmax parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Tmax pharmacokinetic (PK) parameter of paxalisib following administration of [14C] Paxalisib
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of paxalisib in plasma including but not limited to Tmax parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) parameter of paxalisib following administration of [14C] Paxalisib
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of paxalisib in plasma including but not limited to AUC(0-last) and AUC(0-inf) parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Cmax pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of TR in plasma including but not limited to Cmax parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Tmax pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of TR in plasma including but not limited to Tmax parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Assessment of the PK of an oral [14C]-Paxalisib formulation by measurement of TR in plasma including but not limited to AUC(0-last) and AUC(0-inf) parameter
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To evaluate the extent of distribution of TR into blood cells
Evaluation of whole blood:plasma concentration ratios for TR
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide adverse event (AE) safety information for paxalisib
To provide safety information for paxalisib by assessing adverse events.
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide blood pressure vital sign safety information for paxalisib
Measuring and assessing blood pressure in standard clinical units and against reference range.
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide heart rate vital sign safety information for paxalisib
Measuring and assessing heart rate in standard clinical units against reference range.
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide oral temperature vital sign safety information for paxalisib
Measuring and assessing oral temperature in standard clinical units against reference range.
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide respiratory rate vital sign safety information for paxalisib
Measuring and assessing respiratory rate in standard clinical units against reference range .
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide electrocardiogram (ECG) safety information for paxalisib
Determination of standard ECG parameters including but not limited to PR interval, QRS duration, in standard clinical units against reference range
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide physical examination safety information for paxalisib
Assessment of standard clinical whole-body targeted (symptom-driven) physical examination including but not limited to e.g. general appearance, dermatological
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide hematology laboratory safety testing information for paxalisib
Measuring and assessing standard array of hematology parameters (e.g. white blood cell count) in standard clinical unit against reference range.
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide clinical chemistry laboratory safety testing information for paxalisib
Measuring and assessing standard array of clinical chemistry parameters (e.g. cholesterol) in standard clinical unit against reference range
Measured: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202130 Jan 2024

First posted19 Aug 2021
Study start18 Aug 2021
Primary completion30 Mar 2023
Study completion30 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05012670
Sponsor's protocol ID: KZA-0084-102
Other IDs: QSC204878
Status last verified: Mar 2024
First submitted: 4 Aug 2021
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05012670
Acronym / sponsor ID: KZA-0084-102
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Kazia Therapeutics LimitedIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 18 Aug 2021 (actual)
Primary completion: 30 Mar 2023 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 19 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C]-Paxalisib Capsule	Experimental	Drug: [14C]-Paxalisib CapsuleSubjects 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).

Who may qualify

Ages: 30 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy males.
Aged 30 to 65 years inclusive at the time of signing informed consent.
Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
Must be willing and able to communicate and participate in the whole study.
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day).

Key exclusion criteria (29 listed)

Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
Subjects who are, or are immediate family members of, a study site or sponsor employee.
Evidence of current SARS-CoV-2 infection.
History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C]-Paxalisib CapsuleAlso: Phosphoinositide 3-kinase (PI3K) InhibitorEach subject will receive a single dose 15 mg (NMT 3.5 MBq), administered orally in the fasted state with with 240 mL water.	Drug	[14C]-Paxalisib Capsule

Primary outcome

To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])-Paxalisib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

18 secondary outcomes

To determine the routes and rates of elimination of [14C]-Paxalisib
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Tmax pharmacokinetic (PK) parameter of paxalisib following administration of [14C] Paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) parameter of paxalisib following administration of [14C] Paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Cmax pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the Tmax pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To explore the AUC(0-last) and AUC(0-inf) pharmacokinetic (PK) of TR following administration of [14C] Paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To evaluate the extent of distribution of TR into blood cells
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide adverse event (AE) safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide blood pressure vital sign safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide heart rate vital sign safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide oral temperature vital sign safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide respiratory rate vital sign safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide electrocardiogram (ECG) safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide physical examination safety information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide hematology laboratory safety testing information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)
To provide clinical chemistry laboratory safety testing information for paxalisib
Time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Evans, MBChB, MRCS principal investigator

Quotient Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-Paxalisib Capsule in people with Healthy, run by Kazia Therapeutics Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the mass balance recovery after a single oral dose of carbon-14 ([14C])-Paxalisib (time frame: Day 1 to Day 8 (or up to Day 10 if discharge criteria not met at Day 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05012670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.