A Phase I study to investigate pharmacokinetics, safety, and tolerability of two single doses of EU-C-001 given as slow intravenous infusions in healthy female subjects
- Conditions
- Traumatic brain injuryNeurological - Other neurological disorders
- Registration Number
- ACTRN12618000364279
- Lead Sponsor
- PresSura Neuro
- Brief Summary
This study explored the way in which adult females absorb, metabolise and excrete the text drug, EU-C-001. A total of 10 women, aged between 21 and 34 years participated in the study, with an average height of 164 cm and average weight of 60 kg. The test drug, EU-C-001 was measured in the blood and in the urine of the study participants, up to 72 hours after the drug was administered. Most of the participants reported some kind of possible side effect after receiving the drug. All the side effects were mild, except one moderate effect related to a reaction at the injection site. All the side-effects resolved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 10
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method