Brain Injuries, TraumaticPhase 1NCT00961779
Safety Study of NNZ-2566 in Healthy Female Subjects
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 the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy 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
- 39 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2010to Sep 2010
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
- History of any psychiatric illness which may impair the ability to provide written informed consent.
- Poor protocol 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.
- QT/QTc Exclusions i.e., 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 PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).
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.
Read the detailed description
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.
To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.
- 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 Experimental name: NNZ-2566
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.
PlaceboDrug
Also called Sodium Chloride 0.9% Injection
Normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Normal saline infusion) | Placebo comparator | Not described Receives: 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. Receives: Drug: NNZ-2566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs
Measured: Through to Day 7 post end of study drug infusion 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 2009 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionSep 2010
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas J Wilson, MB ChB, PhD, Study director, Neuren Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961779
- Sponsor's protocol ID
- Neu-2566-HV-004
- Status last verified
- Oct 2014
- First submitted
- 17 Aug 2009
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. 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 PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).
- ClinicalTrials.gov ID
- NCT00961779
- Acronym / sponsor ID
- Neu-2566-HV-004
- Conditions
- Brain Injuries, Traumatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Neuren Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Aug 2009 (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 the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers.
Detailed description
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.
To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.
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 (Normal saline infusion) | Placebo comparator | Drug: Placebo |
| NNZ-2566 | Experimental | Drug: NNZ-2566NNZ-2566 reconstituted in bicarbonate buffer and normal saline. 6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (22 listed)
- 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.
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: Experimental name: NNZ-2566Glycyl-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. | Drug | NNZ-2566 |
| PlaceboAlso: Sodium Chloride 0.9% InjectionNormal saline infusion | Drug | Placebo (Normal saline infusion) |
Primary outcome
Incidence of AEs and SAEs
Time frame: Through to Day 7 post end of study drug infusion 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 7 Oct 2014.
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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.
Douglas J Wilson, MB ChB, PhD study director
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 11 inclusion and 22 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 7 Oct 2014. 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 AEs and SAEs (time frame: Through to Day 7 post end of study drug infusion 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 7 Oct 2014.