Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide (NCT07173738) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide
United Kingdom44 participantsStarted 2018-06-11
Plain-language summary
The purpose of this study is:
* To assess the effect of BIA 5 1058 400 mg on furosemide pharmacokinetics (PK).
* To assess the effect of furosemide 40 mg on the PK of BIA 5 1058.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A signed and dated informed consent form before any study-specific screening procedure is performed;
. Males and Females subjects aged 18 to 55 years, inclusive;
. Non-smoker or ex-smokers for at least 3 months prior to screening;
. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
. Subject with no clinically significant history of previous allergy / sensitivity to BIA 5-1058/furosemide or any of the excipients contained within the IMP(s);
. Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
. Healthy as determined by the Investigator based on medical history, physical examination, , vital signs (systolic blood pressure (SBP) ≥ 90 mmHg and ≤ 140 mmHg, diastolic blood pressure (DBP) ≥ 50 mmHg and ≤ 90 mmHg) and digital 12-lead electrocardiogram (ECG));
Exclusion criteria
. Any personal or family history of haemostatic disorder;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum observed concentration (Cmax)
Timeframe: Up to 3 months
2
Time to Cmax (Tmax)
Timeframe: Up to 3 months
3
Elimination rate constant (kel)
Timeframe: Up to 3 months
4
Terminal elimination half-life (t1/2)
Timeframe: Up to 3 months
5
Area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t)
. Consumption of more than 21 units (14 units for female subjects) of alcohol a week \[1 unit corresponds to 1 glass of 12% wine (10 cl), 1 glass of 45% pastis (2.5 cl), 1 glass of 40% whisky (2.5 cl), 1 glass of 12% champagne (10 cl), 1 glass of 18% aperitif drink (7 cl) or one 25-cl glass of 5% beer\];
. Use of nicotine replacement products such as patches, gum and/or electronic cigarettes within 3 months prior to the screening visit;
. Significant infection or known inflammatory process at screening or admission to each treatment period;
. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
. Symptomatic orthostatic hypotension \[drop of \> 20 mmHg in SBP and/or \> 10 mmHg\] in DBP when moving from supine to standing position, together with other symptoms, e.g. dizziness
. Previous use of BIA 5-1058;
. Use of any investigational drug or participation in any clinical trial within 90 days or 5 half-life times, whichever is longer,