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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01420042




Registration number
NCT01420042
Ethics application status
Date submitted
17/08/2011
Date registered
19/08/2011
Date last updated
22/11/2012

Titles & IDs
Public title
Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
Scientific title
A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration
Secondary ID [1] 0 0
Neu-2566-HV-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injuries, Traumatic 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNZ-2566
Treatment: Drugs - Placebo

Placebo comparator: Placebo (lemon flavoured cordial) - NNZ-2566 reconstituted in Lemon flavoured cordial and Water for Injection. 6/8 subjects in each cohort (3 cohorts in total) to receive NNZ-2566 experimental treatment.

Experimental: NNZ-2566 -


Treatment: Drugs: NNZ-2566
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.

Treatment: Drugs: Placebo
Lemon flavoured cordial and Water for Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AE) and serious adverse events (SAE)
Timepoint [1] 0 0
Through to Day 7 post end of study drug administration or until resolved

Eligibility
Key inclusion criteria
* Males: 60.0-100.0 kg, Females: 50.0-100.0 kg (inclusive).
* Males: Body mass index (BMI) of 20-30.0, Females: BMI of 18.5-30.0 kg/m2 (inclusive).
* Healthy, determined by a medical history with particular attention to:

* drug history identifying any known drug allergies and the presence of drug abuse;
* any chronic use of medication
* thorough review of body systems: no clinically significant abnormal findings on physical examination and electrocardiogram (ECG),
* Adequate venous access in arms to allow collection of blood samples.
* Fluent in the English language.
* Have voluntarily given written informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant and lactating females.
* History of allergy/hypersensitivity to any of the ingredients of the formulations
* History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, gynecological, ENT or musculoskeletal disorders, psychiatric disease or hematological disorders.
* Any history of asthma during the last 10 years.
* Creatinine clearance <65 mL/min.
* Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product.
* History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture.
* History of hepatitis B, a positive test for hepatitis B surface antigen, a history of hepatitis C, a positive test for hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
* Any evidence of organ dysfunction, or any clinically significant clinical laboratory value which, in the opinion of the Investigator would jeopardize the safety of the subject or impact on the validity of the study results, including a liver function test (LFT) >1.5 x upper limit of normal (ULN).
* Those who may have difficulty abstaining from alcohol during the 48 hr prior to dose administration and until completion of the Study Exit visit.
* History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse.
* Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study.
* Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements for 14 days prior to dose administration and for the duration of the study, (with the exception of occasional analgesia, vitamin and other nutrient supplement use, at the discretion of the Investigator).
* Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g. coffee, tea, cola and chocolate) during the 48 hrs prior to dose administration and for the duration of the study.
* History of any psychiatric illness which may impair the ability to provide written informed consent.
* Poor compliers or those unlikely to attend.
* Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
* Standard blood donation (usually 550 mL) within the 12-week period before dose administration.
* Unusual dietary habits and excessive or unusual vitamin intakes.
* Vaccination or immunizations within 30 days of initial dose administration.
* Whilst there were no QT/QTc effects seen in the human volunteers at a dose of 20 mg/kg administered intravenously as a 10 min infusion, until the effects of the drug on QT/QTc interval have been formally characterized, the study will use the exclusion criteria defined in International Conference on Harmonisation (ICH) Guideline E14 to exclude subjects with a risk of QT/QTc prolongation, namely:

* A marked baseline prolongation of corrected QT interval >450 ms in two ECGs, or
* A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neuren Pharmaceuticals Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics (PK) of NNZ-2566 in healthy volunteers, when administered orally.
Trial website
https://clinicaltrials.gov/study/NCT01420042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maggie Scott
Address 0 0
Neuren Pharmaceuticals Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01420042