Parkinson's DiseasePhase 1NCT02772614
Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites
A Phase 1 study testing BIA 3-202 (200 mg) in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Switzerland.
Trial summary
The purpose of this study is: To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BIA 3-202 (200 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Feb 2006
- 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 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, 40-55 years of age. Take only Caucasians.
- Clinically acceptable sitting blood pressure and pulse rate , i.e.: BP: 110-160 mmHg systolic, 65-95 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 weight must be between 50 and 95 kg and within -10% / +20% of normal for their height and frame size (according to Metropolitan Life Insurance Table, see Appendix 1\&2 of the Study Protocol). Frame size will be determined using elbow breadth measurement.
- 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.
Who cannot join
- 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.
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- 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) and CK values must be within the normal range.
- Positive results of the drug screening.
- Known hypersensitivity to BIA 3-202.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration
The purpose of this study is:
To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma
Read the detailed description
Monocentre, open, non-placebo-controlled, single-group, single-dose study. Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) were conducted before and after the study, adverse events were monitored throughout the study.
Each subject was to receive a single oral dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg). This was the intended radiolabelled dose without any losses; the actual administered dose was of 2.29 MBq [14C]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the administration until 264 hours thereafter.
Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose.
Urine was sampled before the drug administration (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.
Aliquots of each sample were taken for liquid scintillation counting by the investigator.
Aliquots were separated for determination of parent drug and metabolite patterns.
A baseline faeces sample was obtained during the screening or baseline period. Following dose, each faeces sample was collected in a separate container during the 264 hours post-dose period.
Vomitus (if produced) was collected.
- Conditions
- Parkinson's Disease
- Being tested
- BIA 3-202 (200 mg)
- Keywords
- Nebicapone, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 3-202 (200 mg)Drug
200 mg powder for oral use of unlabelled BIA 3-202
| Study group | Role | What they receive |
|---|---|---|
| Nebicapone (200 mg) | Experimental | Each subject was to receive one single dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg) together with a total of 250 mL non-carbonated water.
The study drug was given after an overnight fast of at least 10 hours after the in-house stay. During waking hours on Day 1, subjects had to have a fluid intake of at least 150 mL per hour starting 1 hour before study drug administration. Receives: Drug: BIA 3-202 (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration (Cmax)
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
time of occurrence of Cmax (tmax)
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (AUC0-t)
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (C(t)/λz), where C(t) is the last quantifiable concentration and λz the apparent terminal rate constant (AUC0-∞)
Measured: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJan 2006
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- 4 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
- NCT02772614
- Sponsor's protocol ID
- BIA-3202-106
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration
- ClinicalTrials.gov ID
- NCT02772614
- Acronym / sponsor ID
- BIA-3202-106
- Conditions
- Parkinson's Disease
- Keywords
- Nebicapone, Parkinson's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 13 May 2016 (estimated)
- 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 this study is:
To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma
Detailed description
Monocentre, open, non-placebo-controlled, single-group, single-dose study. Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) were conducted before and after the study, adverse events were monitored throughout the study.
Each subject was to receive a single oral dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg). This was the intended radiolabelled dose without any losses; the actual administered dose was of 2.29 MBq [14C]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the administration until 264 hours thereafter.
Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose.
Urine was sampled before the drug administration (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.
Aliquots of each sample were taken for liquid scintillation counting by the investigator.
Aliquots were separated for determination of parent drug and metabolite patterns.
A baseline faeces sample was obtained during the screening or baseline period. Following dose, each faeces sample was collected in a separate container during the 264 hours post-dose period.
Vomitus (if produced) was collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nebicapone (200 mg) | Experimental | Drug: BIA 3-202 (200 mg)Each subject was to receive one single dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg) together with a total of 250 mL non-carbonated water. The study drug was given after an overnight fast of at least 10 hours after the in-house stay. During waking hours on Day 1, subjects had to have a fluid intake of at least 150 mL per hour starting 1 hour before study drug administration. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subject, 40-55 years of age. Take only Caucasians.
- Clinically acceptable sitting blood pressure and pulse rate , i.e.: BP: 110-160 mmHg systolic, 65-95 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 weight must be between 50 and 95 kg and within -10% / +20% of normal for their height and frame size (according to Metropolitan Life Insurance Table, see Appendix 1\&2 of the Study Protocol). Frame size will be determined using elbow breadth measurement.
- Normal 12-lead ECG.
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| BIA 3-202 (200 mg)200 mg powder for oral use of unlabelled BIA 3-202 | Drug | Nebicapone (200 mg) |
Primary outcome
maximum plasma concentration (Cmax)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
time of occurrence of Cmax (tmax)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (AUC0-t)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (C(t)/λz), where C(t) is the last quantifiable concentration and λz the apparent terminal rate constant (AUC0-∞)
Time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose
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 13 May 2016.
- 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 BIA 3-202 (200 mg) in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Switzerland.
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 6 inclusion and 17 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 13 May 2016. 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 Switzerland. 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?
maximum plasma concentration (Cmax) (time frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose). The study lists 4 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 13 May 2016.