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 range18 Years – 55 Years

SexALL

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;
✕. 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,

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to 3 months

Time to Cmax (Tmax)

Timeframe: Up to 3 months

Elimination rate constant (kel)

Timeframe: Up to 3 months

Terminal elimination half-life (t1/2)

Timeframe: Up to 3 months

Area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t)

Timeframe: Up to 3 months

AUC extrapolated to infinity (AUC0-inf)

Timeframe: Up to 3 months

Clearance (CL/F)

Timeframe: Up to 3 months

Volume of distribution (Vz/F)

Timeframe: Up to 3 months

Trial details

NCT IDNCT07173738

SponsorBial - Portela C S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-07

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range18 Years – 55 Years

SexALL

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;
✕. 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,

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to 3 months

Time to Cmax (Tmax)

Timeframe: Up to 3 months

Elimination rate constant (kel)

Timeframe: Up to 3 months

Terminal elimination half-life (t1/2)

Timeframe: Up to 3 months

Area under the concentration-time curve (AUC) from time of dosing to last measurable concentration (AUC0-t)

Timeframe: Up to 3 months

AUC extrapolated to infinity (AUC0-inf)

Timeframe: Up to 3 months

Clearance (CL/F)

Timeframe: Up to 3 months

Volume of distribution (Vz/F)

Timeframe: Up to 3 months