Safety Study of NNZ-2566 in Healthy Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuren Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00961779
First received: August 17, 2009
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Brain Injuries, Traumatic
Drug: NNZ-2566
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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).

Resource links provided by NLM:


Further study details as provided by Neuren Pharmaceuticals Limited:

Primary Outcome Measures:
  • Incidence of AEs and SAEs [ Time Frame: Through to Day 7 post end of study drug infusion or until resolved ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Normal saline infusion) Drug: Placebo
Normal saline infusion
Other Name: Sodium Chloride 0.9% Injection
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.
Drug: 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.
Other Name: Experimental name: NNZ-2566

Detailed Description:

To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.

To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961779

Locations
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Neuren Pharmaceuticals Limited
Investigators
Study Director: Douglas J Wilson, MB ChB, PhD Neuren Pharmaceuticals Ltd
  More Information

No publications provided

Responsible Party: Neuren Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00961779     History of Changes
Other Study ID Numbers: Neu-2566-HV-004
Study First Received: August 17, 2009
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014