PharmacokineticsPhase 1NCT04183517
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
A Phase 1 study testing PXS-5382A in people with Pharmacokinetics, run by Syntara at 1 site in Australia.
Trial summary
This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B. For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- PXS-5382A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Dec 2019to 24 Jun 2020
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, aged between 18 and 60 years (inclusive).
- Eligibility of the subjects based on clinical history, physical examination, ECG and Lab results
- BMI between 18.5 kg/m2 and 30.0 kg/m2 inclusive.
- No clinically relevant abnormality in an ECG; QTcF (Fridericia's corrected QT) ≤ 450 ms, PR interval of 120-210 ms and a QRS duration ≤ 120 ms.
- Adequate venous access in the left or right arm to allow dosing and collection of a number of blood samples.
- Male subjects with female partners of childbearing potential may be enrolled if they:
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- are documented to be surgically sterile (vasectomy at least six months prior to dosing), or
- practice true abstinence for 30 days after the study drug administration, or
- agree to use a barrier method of contraception (e.g. condom) from Screening and until 30 days after administration of the study. Additionally, the female partner must use a highly effective hormonal method, such as birth control pills, patches, implants or injections; or used an intra uterine device (IUD).
- Contraceptive requirements do not apply to subjects who are exclusively in same-sex relationships.
- Have given written informed consent to participate in this study in accordance with local regulations.
Who cannot join
- Clinically significant abnormal findings on the physical examination, medical history, ECG or laboratory results as deemed by the PI (or delegate).
- Clinically significant gastrointestinal, renal, hepatic, neurologic, haematologic (including thalassaemia), endocrine, oncologic, pulmonary, immunologic, psychiatric, skin or cardiovascular disease or any other condition, which, in the opinion of the PI (or delegate), would jeopardise the safety of the subject or impacted the validity of the study results.
- History of significant drug allergies or significant allergic reaction or suffer from clinically significant systemic allergic disease. Mild hay fever is acceptable.
- Evidence of abnormal wound healing (e.g. hypertrophic scars) as the result of surgery or trauma as deemed by the PI or delegate.
- Have received or are anticipated to receive any prescription systemic or topical medication, or any over the counter, supplements, complementary or alternative medicine 7 days prior to the start of dosing or within 5 half-lives of the drug whichever is longer (excluding paracetamol).
- Systolic BP < 90 or > 140 mmHg, diastolic BP < 40 or > 90 mmHg and HR < 40 or > 100 beats per minute (BPM).
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- ALT, AST or total bilirubin > 1.5x ULN.
- Gilbert's syndrome sufferers are not eligible.
- Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 80 mL/min at Screening.
- Positive Screening test for Hepatitis B surface antigen or Hepatitis C antibody or human immunodeficiency virus (HIV)
- Any condition directly or indirectly caused by or associated with Transmissible Spongiform Encephalopathy (TSE) Creutzfeldt-Jakob Disease (CJD) variant Creutzfeldt-Jakob Disease (vCJD) or new variant Creutzfeldt-Jakob Disease (nvCJD)
- History of drug abuse in the last 2 years.
- Males who regularly drink more than four (4) units of alcohol daily (1 unit = 285 mL beer (4.9% Alc./Vol), 100 mL wine (12% Alc./Vol), 30 mL spirit (40% Alc./Vol)).
- Use nicotine-containing products (e.g., cigarettes, e-cigarettes, cigars, chewing tobacco, snuff) within 6 weeks before screening and were unable to abstain from using these products until study completion.
- Unable to abstain from consuming caffeine and/or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for defined periods (eg, to the clinical facility).
- Consumption of:
- Grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges (CYP450 enzymes) within 7 days prior to administration of the study drug up to Exit Evaluation visit.
- Poppy seeds and poppy seed products within 7 days prior to administration of the study drug up to Exit Evaluation visit.
- Alcohol within 48 hours prior to administration of study drug up to Exit Evaluation visit.
- Positive urine screen for drugs of abuse and alcohol breath test at screening and study check-in. Subjects may undergo a repeat urine drug screen or alcohol breath test at the discretion of the PI (or delegate).
- Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.
- Have dietary restrictions that preclude the consumption of the required high-fat meal in Part A.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B.
For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Each subject during participation in the study will receive a dose of PXS 5382A orally in a fed state and a fasted state.
For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state and dose will be dependent on analysis of Part A.
In both part A and B PK, PD and safety assessments will be collected.
- Conditions
- Pharmacokinetics
- Being tested
- PXS-5382A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXS-5382ADrug
Orally once daily or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Fasted | Experimental | PXS-5382A administered as a single dose in the fasted state Receives: Drug: PXS-5382A |
| Fed | Experimental | PXS-5382A administered as a single dose in the fed state Receives: Drug: PXS-5382A |
| Twice daily | Experimental | PXS-5382A administered twice daily for 5 days in the fed state Receives: Drug: PXS-5382A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax after oral administration of PXS-5382A
Maximum plasma concentration
Measured: 6 days
Tmax after oral administration of PXS-5382A
Time of the observed maximum plasma concentration
Measured: 6 days
AUC0-inf of PXS-5382A
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
Measured: 6 days
t1/2 of PXS-5382A
Terminal plasma elimination half-life
Measured: 6 days
Secondary outcomes (4)
Maximum percentage inhibition plasma LOXL2 of PXS-5382A
Maximum measured plasma LOXL2 target engagement following PXS-5382A administration
Measured: 6 days
Incidence and severity of Adverse Events
A treatment-emergent adverse events (TEAE) will be summarized by treatment and overall, and summarized for each treatment by severity and relationship to study drug. All TEAEs leading to withdrawal, or SAEs, will be summarized.
Measured: 6 days
Number of subjects with clinical laboratory test abnormalities
The clinical laboratory will include hematology (hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, white blood cell count), clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, cholesterol, creatinine, creatine phosphokinase, direct bilirubin, estimated glomerular filtration rate, gamma glutamyl transferase, glucose. inorganic phosphate, iron, lactate dehydrogenase, phosphorus, potassium, sodium, total bilirubin, total CO2, total protein, triglyceride, urea, uric acid), and urinalysis (bilirubin, blood, color and appearance, glucose, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic examination, electrolytes). Abnormality will be determined by the investigator.
Measured: 6 days
Number of subjects with vital signs abnormalities
The vital sign will include blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (degree Celsius). Abnormality will be determined by the investigator.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start20 Dec 2019
- Primary completion4 Apr 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela Molga, MBBS, Principal investigator, CMAX Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183517
- Sponsor's protocol ID
- PXS-5382A-102
- Status last verified
- Jun 2020
- First submitted
- 26 Nov 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT04183517
- Acronym / sponsor ID
- PXS-5382A-102
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 3 Dec 2019 (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.
This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B.
For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Each subject during participation in the study will receive a dose of PXS 5382A orally in a fed state and a fasted state.
For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state and dose will be dependent on analysis of Part A.
In both part A and B PK, PD and safety assessments will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasted | Experimental | Drug: PXS-5382APXS-5382A administered as a single dose in the fasted state |
| Fed | Experimental | Drug: PXS-5382APXS-5382A administered as a single dose in the fed state |
| Twice daily | Experimental | Drug: PXS-5382APXS-5382A administered twice daily for 5 days in the fed state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males, aged between 18 and 60 years (inclusive).
- Eligibility of the subjects based on clinical history, physical examination, ECG and Lab results
- BMI between 18.5 kg/m2 and 30.0 kg/m2 inclusive.
- No clinically relevant abnormality in an ECG; QTcF (Fridericia's corrected QT) ≤ 450 ms, PR interval of 120-210 ms and a QRS duration ≤ 120 ms.
- Adequate venous access in the left or right arm to allow dosing and collection of a number of blood samples.
Key exclusion criteria (22 listed)
- Clinically significant abnormal findings on the physical examination, medical history, ECG or laboratory results as deemed by the PI (or delegate).
- Clinically significant gastrointestinal, renal, hepatic, neurologic, haematologic (including thalassaemia), endocrine, oncologic, pulmonary, immunologic, psychiatric, skin or cardiovascular disease or any other condition, which, in the opinion of the PI (or delegate), would jeopardise the safety of the subject or impacted the validity of the study results.
- History of significant drug allergies or significant allergic reaction or suffer from clinically significant systemic allergic disease. Mild hay fever is acceptable.
- Evidence of abnormal wound healing (e.g. hypertrophic scars) as the result of surgery or trauma as deemed by the PI or delegate.
- Have received or are anticipated to receive any prescription systemic or topical medication, or any over the counter, supplements, complementary or alternative medicine 7 days prior to the start of dosing or within 5 half-lives of the drug whichever is longer (excluding paracetamol).
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 |
|---|---|---|
| PXS-5382AOrally once daily or twice daily | Drug | Fasted, Fed, Twice daily |
Primary outcome
Cmax after oral administration of PXS-5382A
Time frame: 6 days
Maximum plasma concentration
Tmax after oral administration of PXS-5382A
Time frame: 6 days
Time of the observed maximum plasma concentration
AUC0-inf of PXS-5382A
Time frame: 6 days
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
t1/2 of PXS-5382A
Time frame: 6 days
Terminal plasma elimination half-life
4 secondary outcomes
Maximum percentage inhibition plasma LOXL2 of PXS-5382A
Time frame: 6 days
Incidence and severity of Adverse Events
Time frame: 6 days
Number of subjects with clinical laboratory test abnormalities
Time frame: 6 days
Number of subjects with vital signs abnormalities
Time frame: 6 days
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 25 Jun 2020.
- 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.
Angela Molga, MBBS principal investigator
CMAX Ltd
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 PXS-5382A in people with Pharmacokinetics, run by Syntara at 1 site in Australia.
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 11 inclusion and 22 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 25 Jun 2020. 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 Australia. 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?
Cmax after oral administration of PXS-5382A (time frame: 6 days). 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?
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 25 Jun 2020.