A Single Ascending Dose and Multiple Ascending Dose Phase I Study of PXS-5382A Administered Orally

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis; Non- alcoholic Steatohepatitis; Liver Fibrosis; Kidney Fibrosis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Respiratory - Other respiratory disorders / diseases; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12617001564347
• Lead Sponsor: Pharmaxis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-21
• Study Completion: 2018-10-03
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Healthy males, aged between 18 and 60 years (inclusive).
2. Eligibility of the subjects will be 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 (Fredericia’s corrected QT) > or equals to 450 ms, PR interval of 120-210 ms and a QRS duration < or equals to 120 ms.
5. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
6. Male subjects with female partners of childbearing potential may be enrolled if they:
a. are documented to be surgically sterile (vasectomy at least six months prior to dosing), or
b. practice true abstinence for 30 days after the study drug administration, or
c. 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 use an intra uterine device (IUD).
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

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, 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 impact the validity of the study results.
3. History of significant drug allergies or significant allergic reaction or currently suffers 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 is anticipated to receive any prescription systemic or topical medication, or any over the counter, complimentary 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 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
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)).
Used nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff) within 6 weeks before screening and 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 (e.g., for at least 48 hours prior to admission to the clinical facility, and whilst confined to the clinical facility).
16. Consumption of:
a. Grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges (CYP450 enzymes) within 7 days prior to administration of the study drug.
b. Poppy seeds and poppy seed products within 7 days prior to administration of the study drug.
c. Alcohol within 48 hours prior to administration of study drug and during the conduct of the study.
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. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
20. Have participated in a clinical trial or have received an experimental therapy within 3 months or 5 half-lives of the drug, whichever is the longer, prior to dosing.
21. Clinicall

Study & Design

• Study Type: Interventional
• Study Design: Not specified