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

NCT ID: NCT01420042

Last Updated: 2012-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-09-30

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.

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lemon flavoured cordial and Water for Injection

NNZ-2566

Group Type: EXPERIMENTAL

NNZ-2566

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Lemon flavoured cordial and Water for Injection

Intervention Type: DRUG

Other Intervention Names

NNZ-2566 Lot NNZP25; Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection

Eligibility Criteria

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.

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuren Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maggie Scott

Role: PRINCIPAL_INVESTIGATOR

Neuren Pharmaceuticals Ltd

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

Neu-2566-HV-005

Identifier Type: -

Identifier Source: org_study_id