CompletedPhase 1ACTRN12614001326684

Single Ascending Dose and Multiple Ascending Dose Phase I study of PXS-4728A Administered Orally in Healthy Adult Males.

Single Ascending Dose and Multiple Ascending Dose Phase 1 Study to determine the safety, tolerability, pharmacokinetic and pharmacodynamic parameters of PXS-4728A Administered Orally in Healthy Adult Males

Sponsor

Pharmaxis Ltd.

Enrollment

72 participants

Start Date

Jan 14, 2015

Study Type

Interventional

Conditions

Chronic Obstructive Pulmonary Disease Cystic Fibrosis

Summary

This is the first in human study with PXS-4728A. The primary aim of the study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics and pharmacodynamics of PXS-4728A in healthy males.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria6

healthy males.
BMI - 18.5 to 30 kg/m2.
no clinically relevant abnormality in an ECG; QTcF (QTc Fredericia’s correction) less than or equal to 450 ms, PR interval of 120-210 ms and a QRS duration less than or equal to 120 ms.
adequate venous access.
agree to use two approved methods of contraception from screening and until 30 days after administration of the study drug.
has given written informed consent.

Exclusion Criteria20

clinically significant abnormal findings on the physical examination or medical history.
clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin or cardiovascular disease.
history of significant drug allergies/ allergic reaction or currently suffers from clinically significant systemic allergic disease.
abnormal wound healing as the result of surgery or trauma.
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, whichever is greater, or use any complimentary or alternative medicine 48 hours prior to the start of dosing or within 5 half
lives of the drug whichever is greater (excluding paracetamol).
systolic blood pressure <100 or >140 mmHg, diastolic blood pressure <50 or >90 mmHg and heart rate (HR) <55 or >95 bpm.
ALT, AST or bilirubin >2x ULN.
significant renal insufficiency, with an estimated
creatinine clearance less than 60 mL/min at screening.
positive screening test for HbsAg or Hep C.
history of drug abuse in the last 2 years.
drink more than three (3) units of alcohol daily
used nicotine-containing products within 6 weeks before screening and unable to abstain until study completion.
consumed caffeine and/or xanthine products for at least 48 hours prior to admission to the clinical facility, and whilst confined to the clinical facility.
consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, red wine or other alcohol within 7 days prior to administration of study drug.
positive urine screen for drugs of abuse and alcohol breath test at screening and study check-in.
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.
clinically significant abnormality detected on telemetry pre-dose.
systemic infection other than coryza in the last week prior to dosing

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Interventions

The interventional product, PXS-4728A, is a powder which will be dissolved in water for irrigation (stock solution). The final product will be formulated at 1-20 mg/100 mL in flavoured water at room temperature for oral administration. The study is divided into 2 parts: Part A - Single Ascending Dose (SAD) study in which PXS-4728A will be administered as a single dose (1/ 3/ 6/ 10/ 15 or 20 mg). Part B - Multiple Ascending Dose (MAD) study in which PXS-4728A will be administered once daily from Day 1 up to Day 14. However the dose for this part of the study will be decided based on the results of the SAD study. The interventional product will be administered to the healthy volunteers while they are confined in the clinical facility under the direct supervision of the study team. This will ensure that strict adherence to the intervention are followed.