A double-blind Phase I study to investigate safety, tolerability, andpharmacokinetics of single and repeated escalating doses ofEU-C-001 given as intravenous infusions and as oraladministrations in healthy male subjects

Phase 1

Completed

• Conditions: Traumatic brain injury; Neurological - Other neurological disorders

• Registration Number: ACTRN12616001437459
• Lead Sponsor: PresSura Neuro Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 114

Inclusion Criteria

Gender Male
-Age: Between 18 and 45years
-Weight: 55–95 kg
-BMI: 19–29 kg/m2
-Medical history without clinically relevant pathologies
-Physical examination parameters without signs of clinically relevant pathologies
-Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
-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)
-Subjects must be willing to practice a medically approved method of contraception
(e.g., condom in combination with hormonal contraception or intrauterine device or a
diaphragm after the first drug administration and for one month after participation in
the study or are vasectomized since > 6 months or has a partner being sterilized since
> 6 months
- Having given written informed consent before any study-related activities are carried
out

Exclusion Criteria

-Evidence of clinically relevant pathology or disease
-Evidence of moderate or severe hypertension, hypotension or orthostatic hypotension
(fall in systolic blood pressure of >15 mmHg on standing up from semi-supine)
-Unwilling and/or incapable of giving informed consent
- 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
- Acute or chronic gastrointestinal disorders
- Presence or history of endocrine disorders
-Known hypersensitivity to the study drug or constituent of the study drug
- History of immediate hypersensitivity to any drug,
- Strict vegetarian or vegan
- Regular treatment with medications during three months prior to randomisation
- Receipt of any prescription or non-prescription medication, complementary therapies
including multi-vitamin preparations within 7 -10 days prior to randomization and for
the duration of the study with the exception of paracetamol at a dose less than or equal
to 2g per day
- Participation in a clinical study within 90 days prior to randomization or within 7 halflives
of a previous investigational agent
- Having already received EU-C-001
- Donation of blood within 90 days prior to randomisation
- Receipt of blood, blood products or plasma derivates one year prior to randomisation
- History of use of tobacco or nicotine-containing products within the past three months
- Any history of alcohol abuse or drug addiction
- Positive results at screen for drugs of abuse (cocaine, amphetamine /
methamphetamine, tetrahydrocannabiol, opiates) or alcohol (breath test) at screening
or on admission
- Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2
- Consumption of abnormal quantities of coffee or tea or other caffeinated drinks (i.e.,
more than 5 cups per day [1 cup = 150 ml])
-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
Determining the safety and tolerability of EU-C-001 following single and daily repeated administration for up to 5 days following oral and 15 minute IV infusion by measuring the following: <br>Vital signs: blood pressure, pulse rate and body temperature<br>Cardiac telemetry<br>Blood oxygen saturation by digital oximetry, physical examination<br>Biochemistry, haematology and urinalysis<br>Assessment of adverse events and concomitant medication[Vital signs: 0.5h, 1h, 2h, 4h, 8h,12h and 24h after dosing<br>Cardiac telemetry: continuous for 15 minutes prior and 6 hours after dosing<br>Blood oxygen saturation: 1h, 2h, 4h and 8h after dosing<br>Physical examination at 24 h after dosing]

Secondary Outcome Measures

Name	Time	Method
Determination of the pharmacokinetic profile of EU-C-001 and of its main<br>metabolites after oral and intravenous administrations in both plasma and urine. The pharmacokinetic parameters for EU-C-001 and its metabolites measured in plasma are:<br>AUC0-t , AUC0-infinity , Cmax , tmax , deltaz , and t1/2 under single dose conditions and under single as well as multiple dose conditions. These will be determined from samples taken from subjects in groups 1 to 4.<br>Absolute bioavailability. Accumulation factor.<br>The pharmacokinetic parameters for EU-C-001 and its metabolites<br>measured in urine are: Ae0-24.[Pharmacokinetics in plasma at 15 min, 30 min, 1 h, 1.5 h, 2 h, 2.5 h, 3h, 3.5 h, 4h, 5h, 6 h, 7h, 8h, 10h, 12h, 16h and 24 hours after administration by LS-MS/MS Assay.<br>Pharmacokinetics in urine during the following time intervals: 0h-4h, 4h-8h, 8h-12h, 12h-24h by the LC-MS/MS Assay.]