A phase I, single-dose, double-blind, randomised, dose escalation study to assess the safety, tolerability and pharmacokinetics of NNZ-2566 when administered as a 10-minute infusio

Completed

• Conditions: Traumatic brain injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN67656669
• Lead Sponsor: euren Pharmaceuticals (New Zealand)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

1. Aged between 18 years and 50 years (inclusive)
2. Male only: males must also agree to use adequate contraceptive precautions (unless the subject is surgically sterilised) for the duration of the study and for at least 30 days thereafter
3. Body mass index (BMI) of 18 to 30 kg/m^2
4. Healthy - this will be determined by a medical history with particular attention to:
4.1. A drug history identifying any known drug allergies and the presence of drug abuse
4.2. Any chronic use of medication
4.3. 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 jeopardise the safety of the subject or impact on the validity of the study results
5. Volunteers with adequate venous access in their left and right arm to allow collection of blood samples and drug administration
6. Fluency in the English language
7. Have voluntarily given written informed consent to participate in this study

Exclusion Criteria

1. History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations (including lactose intolerance). A known hypersensitivity to lidocaine or any surgical dressing which may be used in the study procedures.
2. Medical conditions:
2.1. History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders
2.2. Any history of asthma during the last 10 years
2.3. A creatinine clearance of less than 75 ml/min calculated using Cockroft and Gault Formula
2.4. Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs
2.5. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation
2.6. 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 human immunodeficiency virus (HIV) infection or demonstration of HIV antibodies
3. Any evidence of organ dysfunction, or any clinically significant clinical laboratory value which, in the opinion of the investigator would jeopardise the safety of the subject or impact on the validity of the study results, including a liver function test (LFT) greater than 1.5 x upper limit of normal (ULN)
4. Those who may have difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling on day 7
5. 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
6. Medication:
6.1. Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study
6.2. 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)
7. 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 facility
8. History of any psychiatric illness which may impair the ability to provide written informed consent
9. Poor compliers or those unlikely to attend
10. Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
11. Standard blood donation (usually 550 ml) within the 12-week period before dose administration
12. Unusual dietary habits, including vegetarian diets and excessive or unusual vitamin intakes
13. Vaccination or immunisation within 30 days of initial dose administration

Study & Design

• Study Type: Interventional
• Study Design: Not specified