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Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420042
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 22, 2012
Information provided by (Responsible Party):
Neuren Pharmaceuticals Limited

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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Drug: NNZ-2566 Drug: Placebo Phase 1

Detailed Description:

Double-blind, placebo-controlled, randomized (with a 6:2 randomization for active versus placebo) safety, dose-escalation, and pharmacokinetic study of NNZ-2566.

Three cohorts will be sequentially dosed, starting with two cohorts receiving a single dose (6mg/kg followed by 30mg/kg). The third cohort will receive two 100mg/kg doses over the course of one day and following a formal safety review the same subjects will then receive two 100mg/kg doses each day for five days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Placebo
Lemon flavoured cordial and Water for Injection
Other Name: Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection

Experimental: NNZ-2566 Drug: 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.
Other Name: NNZ-2566 Lot NNZP25

Primary Outcome Measures :
  1. Incidence of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Through to Day 7 post end of study drug administration or until resolved ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01420042

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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia
Sponsors and Collaborators
Neuren Pharmaceuticals Limited
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Principal Investigator: Maggie Scott Neuren Pharmaceuticals Ltd
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Responsible Party: Neuren Pharmaceuticals Limited Identifier: NCT01420042    
Other Study ID Numbers: Neu-2566-HV-005
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries