None listed
Conditions
Brief summary
This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. Single oral administrations up to 180 mg EU-C-001 and single intravenous administrations up to 90 mg EU-C-001 have been administered to healthy male subjects. The safety, tolerability and pharmacokinetic information is not yet available in females. Therefore, the present study is planned to investigate the safety, tolerability and the pharmacokinetic characteristics of the medication given intravenously in healthy female subjects and will compare the result from a historical data set obtained from studies in healthy male subjects.
Interventions
Female subjects will receive two single 30-minute intravenous infusions of the study medication EU-C-001, the first an intravenous infusion of 15 mg EU-C-001 and after a wash-out of at least seven days an intravenous infusion of 90 mg EU-C-001.
Sponsors
PresSura Neuro
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Gender Female 2. Age: Between 18 and 45years 3. Weight: 50.0–85.0 kg 4. BMI: 19.0–28.0 kg/m2 5. Medical history without clinically relevant pathologies 6. Physical examination parameters without signs of clinically relevant pathologies 7. Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms 8. Values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the medical investigator (in particular normal values for ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, and bilirubin) 9. For three weeks before the first drug administration and until one month after participation in the study, subjects of childbearing potential must be willing to practice a medically approved highly effective birth control method (e.g., condom in combination with a) hormonal contraception, b) intrauterine device (IUD), or c) intrauterine hormone-releasing system (IUS); sexual abstinence; or has a partner being vasectomized since > 6 months) 10. Having given written informed consent before any study-related activities are carried out 11. Negative serum pregnancy test
Exclusion criteria
1. Being pregnant or breast feeding 2. Evidence of clinically relevant pathology or disease 3. Evidence of moderate or severe hypertension, hypotension or orthostatic hypotension (fall in systolic blood pressure of >20 mmHg on standing up from supine) 4. Unwilling and/or incapable of giving informed consent 5. Having had any previous traumatic brain injury, concussion or unexplained loss of consciousness 6. Any history of clinically important psychiatric illness eg history of depression treated with antidepressant or of any clinically important neurological or neuro-muscular disorders and/or epilepsy 7. Acute or chronic gastrointestinal disorders 8. Presence or history of endocrine disorders 9. Known hypersensitivity to the study drug or constituent of the study drug 10. History of immediate hypersensitivity to any drug, 11. Strict vegetarian or vegan 12. Regular treatment with medications during three months prior to screening (except hormonal contraception or replacement) 13. Receipt of any prescription or non-prescription medication, complementary therapies including multi-vitamin preparations within 14 days prior to the day of the first pharmacokinetic assessment and for the duration of the study with the exception of paracetamol at a dose less than or equal to 2g per day 14. Participation in a clinical study within 90 days prior to randomization or within 7 half-lives of a previous investigational agent 15. Having already received EU-C-001 16. Donation of blood within 90 days prior to screening 17. Receipt of blood, blood products or plasma derivatives one year prior to screening 18. History of use of tobacco or nicotine-containing products within the past three months 19. Any history of alcohol abuse or drug addiction 20. Positive results at screening for drugs of abuse (Methamphetamines / Opiates / Cocaine / Cannabinoids / Phencyclidine / Benzodiazepines / Barbiturates / Methadone / Tricyclic Antidepressants / Amphetamines) or alcohol (breath test) at screening or on admission 21. Positive screen results for HBsAg (except for subjects vaccinated for hepatitis or subjects with past but resolved hepatitis), anti-HCV, or anti-HIV1&2 22. Consumption of abnormal quantities of coffee or tea or other caffeinated drinks (i.e., more than 5 cups per day [1 cup = 150 ml]) 23. Any disease which in the Investigator’s opinion would exclude the subject from the study.
Outcome results
None listed