An open-label, parallel-group Phase I study to assess safety, tolerability, and pharmacokinetics of single doses of EU-C-001 administered with an apomorphine challenge, or when 90 mg EU-C-001 are administered alone twice (two times) a day (BID) for 7 doses in 12-hour intervals
- Conditions
- Traumatic brain injuryNeurological - Other neurological disorders
- Registration Number
- ACTRN12618000482268
- Lead Sponsor
- PresSura Neuro Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 22
Healthy male subjects, age 18 to 45 years, healthy as defined by medical history, physical and biological examinations performed prior to inclusion.
1. Gender Male
2. Age: Between 18 and 45years
3. Weight: 55.0–95.0 kg
4. BMI: 19.0–29.0 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 ALT, AST, Gamma-GT)
9. Having given written informed consent before any study-related activities are carried out
10. Willing and able to use a condom for all sexual intercourse and practice a medically approved method of contraception with female partners (e.g., condom in combination with hormonal contraception or intrauterine device or a diaphragm) throughout the study and for 1 month after the last study drug administration
Subjects will not be eligible for the study, if they fulfill one or more of the following exclusion criteria:
1. Evidence of clinically relevant pathology or disease
2. Evidence of moderate or severe hypertension, hypotension or orthostatic hypotension (fall in systolic blood pressure of >20 mmHg on standing up from supine)
3. Unwilling and/or incapable of giving informed consent
4. 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
5. Having had any previous traumatic brain injury, concussion or unexplained loss of consciousness
6. Acute or chronic gastrointestinal disorders
7. Presence or history of endocrine disorders
8. Known hypersensitivity to the study drug or constituent of the study drug
9. History of immediate hypersensitivity to any drug,
10. Strict vegetarian or vegan
11. Regular treatment with medications during three months prior to screening
12. 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
13. Participation in a clinical study within 90 days prior to randomization or within 7 half-lives of a previous investigational agent
14. Having already received EU-C-001
15. Donation of blood within 90 days prior to screening
16. Receipt of blood, blood products or plasma derivatives one year prior to randomization
17. History of use of tobacco or nicotine-containing products within the past three months
18. Any history of alcohol abuse or drug addiction
19. 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
20. Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2 (except for subjects vaccinated for hepatitis or subjects with past but resolved hepatitis)
21. Consumption of abnormal quantities of coffee or tea or other caffeinated drinks (i.e., more than 5 cups per day [1 cup = 150 ml])
22. Any disease which in the Investigator’s opinion would exclude the subject from the study.
23. Any indication of respiratory impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method