Safety Study of NNZ-2566 in Healthy Female Subjects

NCT00961779 | Completed Phase 1 DMC

• 1 other identifier: Neu-2566-HV-004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs and SAEs

  Through to Day 7 post end of study drug infusion or until resolved

Study Arms (2)

Placebo (Normal saline infusion)

PLACEBO COMPARATOR

Drug: Placebo

NNZ-2566

EXPERIMENTAL

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

Interventions

NNZ-2566 DRUG

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.

Also known as: Experimental name: NNZ-2566

NNZ-2566

Placebo DRUG

Normal saline infusion

Also known as: Sodium Chloride 0.9% Injection

Placebo (Normal saline infusion)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuren Pharmaceuticals Limited: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

trofinetide; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Douglas J Wilson, MB ChB, PhD

  Neuren Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

AU (1)