Brain Injuries, TraumaticPhase 1NCT01420042
Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
A Phase 1 study testing NNZ-2566 in people with Brain Injuries, Traumatic, run by Neuren Pharmaceuticals Limited at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- NNZ-2566
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
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- Adequate venous access in arms to allow collection of blood samples.
- Fluent in the English language.
- Have voluntarily given written informed consent.
Who cannot join
- 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.
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- 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.
- Whilst there were no QT/QTc effects seen in the human volunteers at a dose of 20 mg/kg administered intravenously as a 10 min infusion, until the effects of the drug on QT/QTc interval have been formally characterized, the study will use the exclusion criteria defined in International Conference on Harmonisation (ICH) Guideline E14 to exclude subjects with a risk of QT/QTc prolongation, namely:
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration
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.
Read the 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
- Being tested
- NNZ-2566, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNZ-2566Drug
Also called NNZ-2566 Lot NNZP25
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.
PlaceboDrug
Also called Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection
Lemon flavoured cordial and Water for Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| NNZ-2566 | Experimental | Not described Receives: Drug: NNZ-2566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE) and serious adverse events (SAE)
Measured: Through to Day 7 post end of study drug administration or until resolved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maggie Scott, Principal investigator, Neuren Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420042
- Sponsor's protocol ID
- Neu-2566-HV-005
- Status last verified
- Nov 2012
- First submitted
- 17 Aug 2011
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration
- ClinicalTrials.gov ID
- NCT01420042
- Acronym / sponsor ID
- Neu-2566-HV-005
- Conditions
- Brain Injuries, Traumatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neuren Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (lemon flavoured cordial) | Placebo comparator | Drug: PlaceboNNZ-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. |
| NNZ-2566 | Experimental | Drug: NNZ-2566 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- Adequate venous access in arms to allow collection of blood samples.
- Fluent in the English language.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNZ-2566Also: NNZ-2566 Lot NNZP25Glycyl-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. | Drug | NNZ-2566 |
| PlaceboAlso: Bickford's Bitter Lemon Cordial, 1:1 in Water for InjectionLemon flavoured cordial and Water for Injection | Drug | Placebo (lemon flavoured cordial) |
Primary outcome
Incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: Through to Day 7 post end of study drug administration or until resolved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Scott principal investigator
Neuren Pharmaceuticals Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNZ-2566 in people with Brain Injuries, Traumatic, run by Neuren Pharmaceuticals Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE) and serious adverse events (SAE) (time frame: Through to Day 7 post end of study drug administration or until resolved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.