Back to resultsAbsorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
Primary Purpose
Hypertension, Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
BIA-5-453
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Healthy Caucasian male subjects, 40-55 years of age.
- Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 160 mmHg systolic, 50 95 mmHg diastolic and pulse rate: 50 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
- Subject body mass index must be between 18 and 28 kg/m2
- Normal 12-lead ECG
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
- The subject has given his written informed consent to participate in the study.
Exclusion Criteria:
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
- History of alcohol or drug abuse in the last 5 years.
- Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
- Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
- Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
- Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
- Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
- Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
- History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
- Positive results from the HIV serology.
- Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
- Positive results of the drug screening.
- Known hypersensitivity to BIA 5-453.
- Heavy smokers, i.e., more than 10 cigarettes per day
- Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)
- Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug
Sites / Locations
- Swiss Pharma Contract Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etamicastat
Arm Description
Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules
Outcomes
Primary Outcome Measures
urinary excretion of BIA 5-453 associated radioactivity
following a single 600 mg oral dose labeled with 98 μCi of [14C]
faecal excretion of BIA 5-453 associated radioactivity
baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
amount of BIA 5-453 associated radioactivity present in the expired air
following a single 600 mg oral dose labeled with 98 μCi of [14C]
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03014375
Brief Title
Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
Official Title
An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to:
To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces
Detailed Description
Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and after the study, adverse events will be monitored throughout the study.
Subjects should be hospitalized the day before the administration until 264 hours thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etamicastat
Arm Type
Experimental
Arm Description
Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules
Intervention Type
Drug
Intervention Name(s)
BIA-5-453
Intervention Description
Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
Primary Outcome Measure Information:
Title
urinary excretion of BIA 5-453 associated radioactivity
Description
following a single 600 mg oral dose labeled with 98 μCi of [14C]
Time Frame
pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
Title
faecal excretion of BIA 5-453 associated radioactivity
Description
baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
Time Frame
following a single 600 mg oral dose labeled with 98 μCi of [14C]
Title
amount of BIA 5-453 associated radioactivity present in the expired air
Description
following a single 600 mg oral dose labeled with 98 μCi of [14C]
Time Frame
baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Caucasian male subjects, 40-55 years of age.
Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 160 mmHg systolic, 50 95 mmHg diastolic and pulse rate: 50 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
Subject body mass index must be between 18 and 28 kg/m2
Normal 12-lead ECG
Ability to communicate well with the investigator and comply with the requirements of the entire study.
The subject has given his written informed consent to participate in the study.
Exclusion Criteria:
History of serious adverse reactions or hypersensitivity to any drug.
Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
History of alcohol or drug abuse in the last 5 years.
Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
Positive results from the HIV serology.
Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
Positive results of the drug screening.
Known hypersensitivity to BIA 5-453.
Heavy smokers, i.e., more than 10 cigarettes per day
Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)
Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug
Facility Information:
Facility Name
Swiss Pharma Contract Ltd.
City
Allschwil
ZIP/Postal Code
CH-4123
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
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