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

NCT01420042 | Completed Phase 1 DMC

• 1 other identifier: Neu-2566-HV-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AE) and serious adverse events (SAE)

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

Study Arms (2)

Placebo (lemon flavoured cordial)

PLACEBO COMPARATOR

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

NNZ-2566

EXPERIMENTAL

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 lemon flavoured cordial and Water for Injection.

Also known as: NNZ-2566 Lot NNZP25

NNZ-2566

Placebo DRUG

Lemon flavoured cordial and Water for Injection

Also known as: Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection

Placebo (lemon flavoured cordial)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuren Pharmaceuticals Limited: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

trofinetide; Water; Injections

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)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Maggie Scott

  Neuren Pharmaceuticals Ltd

  PRINCIPAL INVESTIGATOR

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, 2011
• First Posted: August 19, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

AU (1)