Cardiovascular DiseasesPhase 1NCT04069130
Absorption, Distribution, Metabolism and Excretion of [14C] Labelled BIA 5-1058
A Phase 1 study testing 400 mg of BIA 5-1058 in people with Cardiovascular Diseases, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling and structural identification; and determine the routes and rates of elimination of… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- 400 mg of BIA 5-1058
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2019to 2 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males;
- Age 30 to 65 years of age, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive;
- Normal resting supine BP (Systolic BP: 90-140 mmHg [age 18-45] 90 160 mmHg [age >45], Diastolic BP: 40-90 mmHg) and heart rate: 40-90 bpm (age 18-45) 50-90 bpm (age >45) or showing no clinically relevant deviation as judged by the investigator or delegate;
- Digital (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator or delegate;
- All values for clinical laboratory tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the investigator or delegate;
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- Must be willing and able to communicate and participate in the whole study;
- Must have regular bowel movements (ie, average stool production of between ≥1 every 2 days and ≤3 stools per day);
- Must provide written informed consent;
- Must agree to adhere to the contraception requirements
Who cannot join
- Females;
- Subjects who have received any IMP in a clinical research study within the previous 90 days prior to Day 1 of the study;
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee;
- Subjects who have previously received BIA 5-1058 (including participation in QCL118167);
- History of any drug or alcohol abuse in the past 2 years;
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type);
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- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission;
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months;
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study;
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening;
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 2);
- Positive drugs of abuse test result;
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results;
- An estimated creatinine clearance of <90 mL/min based on creatinine clearance calculation using the Cockcroft-Gault equation and normalised to an average surface area of 1.73 m2;
- Clinically significant history of cardiovascular, renal, hepatic, respiratory and particularly GI disease, especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, as judged by the investigator or sub investigator;
- Frequent headaches and/or migraine, recurrent nausea, and/or vomiting (more than twice a month);
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients;
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active;
- Donation or loss of greater than 400 mL of blood within the previous 3 months;
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 2 g paracetamol per day) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor;
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance Recovery, Metabolite Profiling and Identification, of [14C] Labelled BIA 5-1058 Following a Single Oral Dose Administration in Healthy Male Subjects
The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling and structural identification; and determine the routes and rates of elimination of [14C]-BIA 5-1058
Read the detailed description
This is a Phase 1, single-dose, single-centre, single period, open-label, absorption, distribution, metabolism and excretion study in 8 healthy adult male subjects. Subjects will receive a single oral dose of 400 mg [14C]-BIA 5-1058, containing not more than (NMT) 4.6 MBq (124 µCi) 14C, as an oral capsule. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the morning of Day -1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 after an overnight fast of at least 10 hours and will remain resident in the clinic until up to 336 h after dosing (up to Day 15). Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine, faeces and expired air within 2 separate, consecutive 24 h periods. This may result in the subjects being discharged as a group prior to completion of the planned residency period. Once the discharge criteria or the planned residency period has been achieved, collection of all samples (blood, urine, faeces, and expired air) will be stopped and the subjects will undergo discharge assessments. Subjects who have not met the mass balance discharge criteria on Day 15 will return to the clinical unit for up to five further 24-hour residency periods (Days 21-22 [±1 day], 28-29 [±1 day], 42-43 [±2 days], 56-57 [±2 days] and 77-78 [±3 days]) to collect blood samples for PK analysis and urine and faeces samples for analysis of total radioactivity. If the parent and metabolite are below the limit of quantification at any of these visits, subsequent return visits may be cancelled. If by Day 78, levels are not below the limit of quantification or if the additional 24 h residency periods are not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects.
- Conditions
- Cardiovascular Diseases
- Being tested
- 400 mg of BIA 5-1058
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg of BIA 5-1058Drug
1 x 400 mg capsule Oral, Fasted
| Study group | Role | What they receive |
|---|---|---|
| BIA 5 | Experimental | single oral dose of 400 mg as an oral capsule Receives: Drug: 400 mg of BIA 5-1058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ae(urine) - amount excreted in urine
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Ae(faeces) - amount excreted in faeces
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Ae(expired air) - amount excreted in expired air
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Ae(total) - amount excreted in urine, faeces and expired air combined
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
CumAe(urine) - cumulative amount excreted in urine
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
CumAe(faeces) - cumulative amount excreted in faeces
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
CumAe(expired air) - cumulative amount excreted in expired air
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
CumAe(total) - cumulative amount excreted in urine, faeces and expired air combined
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
%Ae(urine) - amount excreted in urine expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
%Ae(faeces) - amount excreted in faeces expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
%Ae(expired air) - amount excreted in expired air expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
%Ae(total) - amount excreted in urine, faeces and expired air combined expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Cum%Ae(urine) - cumulative amount excreted in urine expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Cum%Ae(faeces) - cumulative amount excreted in faeces expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Cum %Ae(expired air) - cumulative amount excreted in expired air expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Cum %Ae(total) - cumulative amount excreted in urine, faeces and expired air combined expressed as a percentage of the administered dose
Calculation of Mass balance of total radioactivity
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Tmax- the time from dosing at which Cmax was apparent
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Cmax - maximum observed concentration
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
C24 - plasma concentration at 24 h
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
AUC(0-last) - area under the curve from 0 time to last measurable concentration
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
AUC(0-inf) - area under the curve from 0 time extrapolated to infinity
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
AUC%extrap - percentage of AUC(0-inf) extrapolated beyond last measured time point
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Lambda-z - the slope of the apparent elimination phase
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Kel - elimination rate constant
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
T1/2 - the apparent elimination half-life
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
CL/F - total body clearance after extravascular administration (for BIA 5 1058 in plasma only)
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Vz/F - apparent volume of distribution based on the terminal phase after extravascular administration (for BIA 5 1058 in plasma only).
Pharmacokinetic Data Analysis
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start22 Jan 2019
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069130
- Sponsor's protocol ID
- BIA-51058-119
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2019
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance Recovery, Metabolite Profiling and Identification, of [14C] Labelled BIA 5-1058 Following a Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04069130
- Acronym / sponsor ID
- BIA-51058-119
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling and structural identification; and determine the routes and rates of elimination of [14C]-BIA 5-1058
Detailed description
This is a Phase 1, single-dose, single-centre, single period, open-label, absorption, distribution, metabolism and excretion study in 8 healthy adult male subjects. Subjects will receive a single oral dose of 400 mg [14C]-BIA 5-1058, containing not more than (NMT) 4.6 MBq (124 µCi) 14C, as an oral capsule. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the morning of Day -1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 after an overnight fast of at least 10 hours and will remain resident in the clinic until up to 336 h after dosing (up to Day 15). Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine, faeces and expired air within 2 separate, consecutive 24 h periods. This may result in the subjects being discharged as a group prior to completion of the planned residency period. Once the discharge criteria or the planned residency period has been achieved, collection of all samples (blood, urine, faeces, and expired air) will be stopped and the subjects will undergo discharge assessments. Subjects who have not met the mass balance discharge criteria on Day 15 will return to the clinical unit for up to five further 24-hour residency periods (Days 21-22 [±1 day], 28-29 [±1 day], 42-43 [±2 days], 56-57 [±2 days] and 77-78 [±3 days]) to collect blood samples for PK analysis and urine and faeces samples for analysis of total radioactivity. If the parent and metabolite are below the limit of quantification at any of these visits, subsequent return visits may be cancelled. If by Day 78, levels are not below the limit of quantification or if the additional 24 h residency periods are not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIA 5 | Experimental | Drug: 400 mg of BIA 5-1058single oral dose of 400 mg as an oral capsule |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy males;
- Age 30 to 65 years of age, inclusive;
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive;
- Normal resting supine BP (Systolic BP: 90-140 mmHg [age 18-45] 90 160 mmHg [age >45], Diastolic BP: 40-90 mmHg) and heart rate: 40-90 bpm (age 18-45) 50-90 bpm (age >45) or showing no clinically relevant deviation as judged by the investigator or delegate;
- Digital (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator or delegate;
Key exclusion criteria (21 listed)
- Females;
- Subjects who have received any IMP in a clinical research study within the previous 90 days prior to Day 1 of the study;
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee;
- Subjects who have previously received BIA 5-1058 (including participation in QCL118167);
- History of any drug or alcohol abuse in the past 2 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400 mg of BIA 5-10581 x 400 mg capsule Oral, Fasted | Drug | BIA 5 |
Primary outcome
Ae(urine) - amount excreted in urine
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Ae(faeces) - amount excreted in faeces
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Ae(expired air) - amount excreted in expired air
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Ae(total) - amount excreted in urine, faeces and expired air combined
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
CumAe(urine) - cumulative amount excreted in urine
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
CumAe(faeces) - cumulative amount excreted in faeces
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
CumAe(expired air) - cumulative amount excreted in expired air
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
CumAe(total) - cumulative amount excreted in urine, faeces and expired air combined
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
%Ae(urine) - amount excreted in urine expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
%Ae(faeces) - amount excreted in faeces expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
%Ae(expired air) - amount excreted in expired air expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
%Ae(total) - amount excreted in urine, faeces and expired air combined expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Cum%Ae(urine) - cumulative amount excreted in urine expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Cum%Ae(faeces) - cumulative amount excreted in faeces expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Cum %Ae(expired air) - cumulative amount excreted in expired air expressed as a percentage of the administered dose
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Cum %Ae(total) - cumulative amount excreted in urine, faeces and expired air combined expressed as a percentage of the administered dose
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Calculation of Mass balance of total radioactivity
Tmax- the time from dosing at which Cmax was apparent
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
Cmax - maximum observed concentration
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
C24 - plasma concentration at 24 h
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
AUC(0-last) - area under the curve from 0 time to last measurable concentration
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
AUC(0-inf) - area under the curve from 0 time extrapolated to infinity
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
AUC%extrap - percentage of AUC(0-inf) extrapolated beyond last measured time point
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
Lambda-z - the slope of the apparent elimination phase
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
Kel - elimination rate constant
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
T1/2 - the apparent elimination half-life
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
CL/F - total body clearance after extravascular administration (for BIA 5 1058 in plasma only)
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
Vz/F - apparent volume of distribution based on the terminal phase after extravascular administration (for BIA 5 1058 in plasma only).
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.
Pharmacokinetic Data Analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 400 mg of BIA 5-1058 in people with Cardiovascular Diseases, run by Bial - Portela C S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ae(urine) - amount excreted in urine (time frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15.). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.