A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males

NCT ID: NCT04183517

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2020-06-24

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasted

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

Group Type: EXPERIMENTAL

PXS-5382A

Intervention Type: DRUG

Orally once daily or twice daily

Fed

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

Group Type: EXPERIMENTAL

PXS-5382A

Intervention Type: DRUG

Orally once daily or twice daily

Twice daily

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

Group Type: EXPERIMENTAL

PXS-5382A

Intervention Type: DRUG

Orally once daily or twice daily

Interventions

PXS-5382A

Orally once daily or twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Syntara

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Molga, MBBS

Role: PRINCIPAL_INVESTIGATOR

CMAX Ltd

Locations

CMAX

Adelaide, , Australia

Countries

Australia

Other Identifiers

PXS-5382A-102

Identifier Type: -

Identifier Source: org_study_id