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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04183517




Registration number
NCT04183517
Ethics application status
Date submitted
26/11/2019
Date registered
3/12/2019

Titles & IDs
Public title
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
Scientific title
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
Secondary ID [1] 0 0
PXS-5382A-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PXS-5382A

Experimental: Fasted - PXS-5382A administered as a single dose in the fasted state

Experimental: Fed - PXS-5382A administered as a single dose in the fed state

Experimental: Twice daily - PXS-5382A administered twice daily for 5 days in the fed state


Treatment: Drugs: PXS-5382A
Orally once daily or twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax after oral administration of PXS-5382A
Timepoint [1] 0 0
6 days
Primary outcome [2] 0 0
Tmax after oral administration of PXS-5382A
Timepoint [2] 0 0
6 days
Primary outcome [3] 0 0
AUC0-inf of PXS-5382A
Timepoint [3] 0 0
6 days
Primary outcome [4] 0 0
t1/2 of PXS-5382A
Timepoint [4] 0 0
6 days
Secondary outcome [1] 0 0
Maximum percentage inhibition plasma LOXL2 of PXS-5382A
Timepoint [1] 0 0
6 days
Secondary outcome [2] 0 0
Incidence and severity of Adverse Events
Timepoint [2] 0 0
6 days
Secondary outcome [3] 0 0
Number of subjects with clinical laboratory test abnormalities
Timepoint [3] 0 0
6 days
Secondary outcome [4] 0 0
Number of subjects with vital signs abnormalities
Timepoint [4] 0 0
6 days

Eligibility
Key inclusion criteria
1. Healthy males, aged between 18 and 60 years (inclusive).
2. Eligibility of the subjects based on clinical history, physical examination, ECG and Lab results
3. BMI between 18.5 kg/m2 and 30.0 kg/m2 inclusive.
4. 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.
5. Adequate venous access in the left or right arm to allow dosing and collection of a number of blood samples.
6. Male subjects with female partners of childbearing potential may be enrolled if they:

1. are documented to be surgically sterile (vasectomy at least six months prior to dosing), or
2. practice true abstinence for 30 days after the study drug administration, or
3. 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).
4. Contraceptive requirements do not apply to subjects who are exclusively in same-sex relationships.
7. Have given written informed consent to participate in this study in accordance with local regulations.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant abnormal findings on the physical examination, medical history, ECG or laboratory results as deemed by the PI (or delegate).
2. 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.
3. History of significant drug allergies or significant allergic reaction or suffer from clinically significant systemic allergic disease. Mild hay fever is acceptable.
4. Evidence of abnormal wound healing (e.g. hypertrophic scars) as the result of surgery or trauma as deemed by the PI or delegate.
5. 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).
6. Systolic BP < 90 or > 140 mmHg, diastolic BP < 40 or > 90 mmHg and HR < 40 or > 100 beats per minute (BPM).
7. ALT, AST or total bilirubin > 1.5x ULN.
8. Gilbert's syndrome sufferers are not eligible.
9. 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.
10. Positive Screening test for Hepatitis B surface antigen or Hepatitis C antibody or human immunodeficiency virus (HIV)
11. 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)
12. History of drug abuse in the last 2 years.
13. 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)).
14. 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.
15. 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).
16. Consumption of:

1. 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.
2. Poppy seeds and poppy seed products within 7 days prior to administration of the study drug up to Exit Evaluation visit.
3. Alcohol within 48 hours prior to administration of study drug up to Exit Evaluation visit.
17. 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).
18. 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.
19. Have dietary restrictions that preclude the consumption of the required high-fat meal in Part A.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/06/2020
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Syntara
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angela Molga, MBBS
Address 0 0
CMAX Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04183517