Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000479606
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
9/05/2014
Date last updated
3/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 284530 0
Protocol code NP202-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac remodelling post acute myocardial infarction 291791 0
Condition category
Condition code
Cardiovascular 292152 292152 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NP202 oral capsules

Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 50, 200, 600, 1000 or 1600mg and followed up to Day 7.

Part B: 3 cohorts of healthy volunteers each receiving one dose per day for 14 days, and followed up to Day 21. Dose levels to be determined after Part A is complete, based on review of Part A safety and PK data. Each cohort will have a single dose level.

All subjects (Parts A and B) will be resident in clinic for dosing. This will ensure dosing compliance.

In each cohort 75% of subjects will receive NP202 and 25% will receive placebo.
Intervention code [1] 289290 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules containing microcellulose.

As this is a blinded study dosing periods and times will be the same as for subjects receiving NP202.

In each cohort 25% of subjects will receive placebo and 75% will receive NP202
Control group
Placebo

Outcomes
Primary outcome [1] 292031 0
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.
Timepoint [1] 292031 0
Monitored and recorded until 7 days post dose
Primary outcome [2] 292032 0
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.
Timepoint [2] 292032 0
Monitored and recorded until 21 days post first dose.
Secondary outcome [1] 308037 0
Pharmacokinetic profiles (Cmax, Tmax, T1/2, AUCt, AUCinf and clearance) of NP202 in serum and urine after single and multiple doses.
Timepoint [1] 308037 0
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

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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2014
Actual
10/06/2014
Date of last participant enrolment
Anticipated
Actual
7/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289164 0
Commercial sector/Industry
Name [1] 289164 0
NeuProtect Pty Ltd
Country [1] 289164 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NeuProtect Pty Ltd
Address
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 287833 0
None
Name [1] 287833 0
Address [1] 287833 0
Country [1] 287833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290936 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 290936 0
Ethics committee country [1] 290936 0
Australia
Date submitted for ethics approval [1] 290936 0
02/04/2014
Approval date [1] 290936 0
07/05/2014
Ethics approval number [1] 290936 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48062 0
Dr Jason Lickliter
Address 48062 0
Nucleus Network
Level 5 Burnet Building
89 Commercial Road
Melbourne Victoria 3004
Country 48062 0
Australia
Phone 48062 0
+61 3 9076 8906
Fax 48062 0
Email 48062 0
[email protected]
Contact person for public queries
Name 48063 0
Grant McLachlan
Address 48063 0
NeuProtect Pty Ltd
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country 48063 0
Australia
Phone 48063 0
+61 3 9654 2121
Fax 48063 0
Email 48063 0
[email protected]
Contact person for scientific queries
Name 48064 0
Grant McLachlan
Address 48064 0
NeuProtect Pty Ltd
Level 1
120 Jolimont Road
East Melbourne VIC 3002
Country 48064 0
Australia
Phone 48064 0
+61 3 9654 2121
Fax 48064 0
Email 48064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.