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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00961779




Registration number
NCT00961779
Ethics application status
Date submitted
17/08/2009
Date registered
19/08/2009
Date last updated
7/10/2014

Titles & IDs
Public title
Safety Study of NNZ-2566 in Healthy Female Subjects
Scientific title
A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability and PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).
Secondary ID [1] 0 0
Neu-2566-HV-004
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 (Normal saline infusion) -

Experimental: NNZ-2566 - NNZ-2566 reconstituted in bicarbonate buffer and normal saline. 6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment.


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 bicarbonate buffer and normal saline.

Treatment: Drugs: Placebo
Normal saline infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of AEs and SAEs
Timepoint [1] 0 0
Through to Day 7 post end of study drug infusion or until resolved

Eligibility
Key inclusion criteria
- Aged between 18 years and 50 years (inclusive).

- Females only.

- Weight 50 to 105 kg

- BMI of 18 to 30 kg/m2.

- General Health: Healthy, determined by a medical history with particular attention to:

- a drug history identifying any known drug allergies and the presence of drug
abuse;

- any chronic use of medication; and

- a thorough review of body systems. This will also be determined by having no
clinically significant abnormal findings on physical examination, which includes
an electrocardiogram (ECG), which in the opinion of the Investigator would
jeopardize the safety of the subject or impact on the validity of the study
results.

- Venous Access: Volunteers with adequate venous access in their left and right arm to
allow collection of blood samples and drug administration.

- Language: Fluent in the English language.

- Informed Consent: Have voluntarily given written informed consent to participate in
this study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant and lactating females are excluded from participating in the study.

- History of allergy and/or hypersensitivity to any of the stated ingredients of the
formulations.

- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular,
dermatological, immunological, respiratory, endocrine, oncological, neurological,
metabolic, psychiatric disease or hematological disorders.

- Any history of asthma during the last 10 years.

- A creatinine clearance of less than 75 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
or intravenous cannulation.

- 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.

- Pregnancy.

- Any evidence of organ dysfunction, or any clinically significant clinical laboratory
value, including a liver function test (LFT) > 1.5 x upper limit of normal (ULN).

- Difficulty abstaining from alcohol during the 48 hours prior to dose administration
and until completion of blood sampling at exit assessment.

- 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 24 hours prior to dose
administration and whilst confined at the clinical study facility.

- History of any psychiatric illness which may impair the ability to provide written
informed consent.

- Poor protocol 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.

- QT/QTc Exclusions i.e., 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
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - 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 the safety of NNZ-2566 in healthy female
volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female
volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00961779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas J Wilson, MB ChB, PhD
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/ct2/show/NCT00961779