A Phase I Randomised, Double-Blind, Placebo-Controlled Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Oral NP202 in Adult Healthy Volunteers

Phase 1

Completed

• Conditions: Cardiac remodelling post acute myocardial infarction; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000479606
• Lead Sponsor: euProtect Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Subjects who;
- Provide written informed consent.
- Are male aged 18 to 45 years old inclusive at the time of consent.
- Have a body mass index (BMI) <30 Kg/m2.
- Have adequate venous access to allow collection of multiple blood samples during the study

Exclusion Criteria

Subjects who:
- Have received blood products within 1 month prior to Screening.
- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
- Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- Have a history of severe or life-threatening drug allergy and/or known drug hypersensitivity.
- Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Have a current malignancy or previous malignancy that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
- Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to Screening, a history of suicide plan
- Have any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead electrocardiogram (ECG)
- Have positive Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Screening test results
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder
- Have clinical signs of active infection and/or a temperature of >38.0 degrees C at the time of screening.
- Have evidence of drug or alcohol abuse, or positive urine screen for drugs of abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of a single dose of NP202 in healthy volunteers (Part A) as assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG, evaluation of adverse events and concomitant medications.[Monitored and recorded until 7 days post dose ];Safety and tolerability of repeat doses of NP202 when administered to healthy volunteers (Part B) as assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG, evaluation of adverse events and concomitant medications.<br>[Monitored and recorded until 21 days post first dose.]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profiles (Cmax, Tmax, T1/2, AUCt, AUCinf and clearance) of NP202 in serum and urine after single and multiple doses. [Single dose (Part A): At 15, 30 and 45 mins and 1, 2, 4, 6, 8, 12, 24 and 48 hours and 7 days post dose<br><br>Multidose (Part B): At 15, 30 and 45 mins and 1, 2, 4, 6, 8, 12 and 24 hours post dose 1, pre doses 2 to 14, and days 15 and 21]