A Single Ascending Dose and Multiple Ascending Dose Phase 1 Study of PXS-5505A Administered Orally in Healthy Adult Males
- Conditions
- Organ FibrosisInflammatory and Immune System - Connective tissue diseases
- Registration Number
- ACTRN12619000332123
- Lead Sponsor
- Pharmaxis Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 56
1. Male and aged between 18 and 60 years (inclusive).
2. Body Mass Index (BMI) between 18.5 kg/m2 and 30 kg/m2 (inclusive).
3. No clinically relevant abnormality in an ECG
4. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
5. Agrees to use a condom, and in the case of partner who is potentially childbearing at least 1 other method of contraception, from Screening until 30 days after administration of the study drug. Agreed methods of contraception may include approved birth control pills, patches, implants or injections by the subject’s partner, use of an IUD (intra uterine device) by the subject’s partner and/or surgical sterilisation of the participant (vasectomy at least 6 months prior to dosing).
6. Have given written informed consent to participate in this study in accordance with local regulations.
1. Clinically significant abnormal findings on the physical examination or medical history
2. Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin or cardiovascular disease or any other condition, that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
3. History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease.
4. Presence of a currently healing wound, recent musculoskeletal injury or currently healing fracture.
5. Have received or is anticipated to receive any prescription systemic or topical medication within 14 days prior to the start of dosing or within 5 half-lives of the drug, or use of any over-the-counter, complementary or alternative medicine 48 hours prior to the start of dosing
6. At Investigator discretion if systolic blood pressure less than 100 or greater than 160 mmHg, diastolic blood pressure less than 50 or greater than 95 mmHg and heart rate (HR) less than 45 or greater than 100 beats per minute.
7. Alanine aminotransferase (ALT), aspartate transaminase (AST), or bilirubin greater than 1.5x upper limit of normal (ULN).
8. Haemoglobin (Hb), white blood cells (WBC), neutrophils, platelets less than LLN.
9. Evidence of significant renal insufficiency
10. Positive screening test for Hepatitis B surface antigen or Hepatitis C antibody or human immunodeficiency virus (HIV).
11. History of drug abuse in the last 2 years.
12.Males who regularly drink more than 3 units of alcohol daily
15. Used nicotine-containing products
14.Unable to abstain from consuming caffeine and/or xanthine products
15. Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, apple juice, red wine or other alcohol within 7 days prior to administration of study drug until 24 hours after the last dose is administered to the subject.
16. Positive urine screen for drugs of abuse and alcohol breath test
17. 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.
18. Any condition that would interfere with drug absorption
19. Have participated in a clinical trial or have received an experimental therapy within 30 days or 5 half-lives of the drug,
21. Systemic infection other than common cold in the week prior to dosing.
22. Have received any vaccines within 30 days before the first dose administration and during the conduct of the study.
23. Consumption of foods containing appreciable amounts of collagen, including meats, meat products, gravy, confectionary and ice-cream containing gelatin,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method