Parkinson DiseasePhase 1NCT03095105
Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects
A Phase 1 study testing 200 mg BIA 6-512 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Germany.
Trial summary
the purpose of the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy elderly subjects versus healthy young subjects after single and repeated oral administration of 200 mg BIA 6-512. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 200 mg BIA 6-512
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2006to 2 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged between 18 and 40 years, inclusive (young); or male or female subjects aged 65 years or more (elderly).
- Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Healthy as determined by an inter¬view, pre-study medical history, physical examination, vital signs, neurological examination and 12-lead ECG; clinical laboratory test results clinically acceptable at screening and admission.
- Negative tests for HBsAg, anti-HCVAb, anti-HIV-1 Ab and anti-HIV-2 Ab at screening.
- Negative screen for drugs of abuse at screening and admission.
- Informed consent signed by the subject.
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- Co-operative and available for the entire study.
- Abstinence from alcohol for 48 hours prior to admission (as stated by subject). An alcohol breath test performed at screening and at admission to the clinic had to be negative.
- Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
- If female, in the young group: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence; and she had a negative urine pregnancy test at screening and admission.
Who cannot join
- Evidence in the subject's medical history or in the medical exa¬mina¬tion of any clinically significant respiratory, hepatic, renal, gastrointesti¬nal, haematological, lymphatic, neurological, car¬diovascu¬lar, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue or other significant acute or chronic abnormalities which might influence either the safety of the subject or the ab¬sorption, dis¬tribution, meta¬bolism or excretion of the active agent under investigation.
- History of relevant drug or food hypersensitivity.
- Significant infection or known inflammatory process on screening or admission.
- Acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Regular use of any medication within four weeks prior to study admission (self-medication or prescription).
- Single use of any medication (including OTC) that was not expressly permitted within two weeks prior admission to the stu¬dy.
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- Abuse of alcohol (equiv¬alent to more than 35 g ethanol per day).
- Vegetarians, vegans or subjects who had medical dietary restrictions.
- History of alcoholism or drug abuse.
- Participation in a clinical investigation within two months prior to screening.
- Blood donation of more than 250 ml within two months prior to screening. Blood donation of less than 250 ml or plasma donation with¬in one month prior to screening.
- Subjects who were known or suspected:
- not to comply with the study directives
- not to be reliable or trustworthy
- not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
- If female, in the young group: she was pregnant or breast-feeding; she was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)
the purpose of the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy elderly subjects versus healthy young subjects after single and repeated oral administration of 200 mg BIA 6-512.
Read the detailed description
Single-centre, open-label study in healthy young (18-40 years) and elderly (65 years or older) subjects. The study consisted of a single-dose phase followed by a repeated dose phase (3 times daily, at 8-h intervals). Subjects were admitted on the day prior to the first dose (Day 1). On day 1, a single dose of 200 mg BIA 6-512 (Dose 1) was administered in the morning. On day 2, the repeated dose phase started 24 h post first dosing. In the repeated dose phase (Doses 2 to 8) subjects received 200 mg BIA 6-512 every 8 hours until the morning of day 4 (approximately 72 hours post first dosing).
- Conditions
- Parkinson Disease
- Being tested
- 200 mg BIA 6-512
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg BIA 6-512Drug
Also called Trans-resveratrol
capsules containing BIA 6-512 200 mg was administered orally, with 240 mL of mineral water without gas at room tempera¬ture
| Study group | Role | What they receive |
|---|---|---|
| Young group | Experimental | The study was performed in two consecutive phases: single-dose and multiple-dose.
Subjects were institutionalised on Day 0, the day prior to the single-dose administration (Day 1). Single dose (dose 1) of BIA 6-512 200 mg was administered on Day 1 and subjects remained confined in the Unit until the 24 h post-dose procedures (Day 2). Then, subjects started being administered BIA 6-512 200 mg thrice-daily until the morning of Day 4 (Dose 8). Blood samples were taken at pre-determined time-points for the assay of BIA 6-512 Receives: Drug: 200 mg BIA 6-512 |
| Elderly group | Experimental | The study was performed in two consecutive phases: single-dose and multiple-dose.
Subjects were institutionalised on Day 0, the day prior to the single-dose administration (Day 1). Single dose (dose 1) of BIA 6-512 200 mg was administered on Day 1 and subjects remained confined in the Unit until the 24 h post-dose procedures (Day 2). Then, subjects started being administered BIA 6-512 200 mg thrice-daily until the morning of Day 4 (Dose 8). Blood samples were taken at pre-determined time-points for the assay of BIA 6-512 Receives: Drug: 200 mg BIA 6-512 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - the maximum observed plasma concentration (single dose)
Measured: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
AUCτ- the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (Single dose)
Measured: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (single dose)
Measured: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
Cmax - the maximum observed plasma concentration (multiple dose)
Effect of age on the BIA 6-512 pharmacokinetics
Measured: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
AUCτ - the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (multiple dose)
Effect of age on the BIA 6-512 pharmacokinetics
Measured: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (multiple dose)
Effect of age on the BIA 6-512 pharmacokinetics
Measured: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start24 Jan 2006
- Primary completion2 Mar 2006
- Study completion2 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT03095105
- Sponsor's protocol ID
- BIA-6512-105
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)
- ClinicalTrials.gov ID
- NCT03095105
- Acronym / sponsor ID
- BIA-6512-105
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2006 (actual)
- Primary completion
- 2 Mar 2006 (actual)
- Study completion
- 2 Mar 2006 (actual)
- First posted
- 29 Mar 2017 (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 was to the compare pharmacokinetic profile of BIA 6-512 in healthy elderly subjects versus healthy young subjects after single and repeated oral administration of 200 mg BIA 6-512.
Detailed description
Single-centre, open-label study in healthy young (18-40 years) and elderly (65 years or older) subjects. The study consisted of a single-dose phase followed by a repeated dose phase (3 times daily, at 8-h intervals). Subjects were admitted on the day prior to the first dose (Day 1). On day 1, a single dose of 200 mg BIA 6-512 (Dose 1) was administered in the morning. On day 2, the repeated dose phase started 24 h post first dosing. In the repeated dose phase (Doses 2 to 8) subjects received 200 mg BIA 6-512 every 8 hours until the morning of day 4 (approximately 72 hours post first dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young group | Experimental | Drug: 200 mg BIA 6-512The study was performed in two consecutive phases: single-dose and multiple-dose. Subjects were institutionalised on Day 0, the day prior to the single-dose administration (Day 1). Single dose (dose 1) of BIA 6-512 200 mg was administered on Day 1 and subjects remained confined in the Unit until the 24 h post-dose procedures (Day 2). Then, subjects started being administered BIA 6-512 200 mg thrice-daily until the morning of Day 4 (Dose 8). Blood samples were taken at pre-determined time-points for the assay of BIA 6-512 |
| Elderly group | Experimental | Drug: 200 mg BIA 6-512The study was performed in two consecutive phases: single-dose and multiple-dose. Subjects were institutionalised on Day 0, the day prior to the single-dose administration (Day 1). Single dose (dose 1) of BIA 6-512 200 mg was administered on Day 1 and subjects remained confined in the Unit until the 24 h post-dose procedures (Day 2). Then, subjects started being administered BIA 6-512 200 mg thrice-daily until the morning of Day 4 (Dose 8). Blood samples were taken at pre-determined time-points for the assay of BIA 6-512 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects aged between 18 and 40 years, inclusive (young); or male or female subjects aged 65 years or more (elderly).
- Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Healthy as determined by an inter¬view, pre-study medical history, physical examination, vital signs, neurological examination and 12-lead ECG; clinical laboratory test results clinically acceptable at screening and admission.
- Negative tests for HBsAg, anti-HCVAb, anti-HIV-1 Ab and anti-HIV-2 Ab at screening.
- Negative screen for drugs of abuse at screening and admission.
Key exclusion criteria (17 listed)
- Evidence in the subject's medical history or in the medical exa¬mina¬tion of any clinically significant respiratory, hepatic, renal, gastrointesti¬nal, haematological, lymphatic, neurological, car¬diovascu¬lar, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue or other significant acute or chronic abnormalities which might influence either the safety of the subject or the ab¬sorption, dis¬tribution, meta¬bolism or excretion of the active agent under investigation.
- History of relevant drug or food hypersensitivity.
- Significant infection or known inflammatory process on screening or admission.
- Acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Regular use of any medication within four weeks prior to study admission (self-medication or prescription).
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 |
|---|---|---|
| 200 mg BIA 6-512Also: Trans-resveratrolcapsules containing BIA 6-512 200 mg was administered orally, with 240 mL of mineral water without gas at room tempera¬ture | Drug | Elderly group, Young group |
Primary outcome
Cmax - the maximum observed plasma concentration (single dose)
Time frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
AUCτ- the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (Single dose)
Time frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (single dose)
Time frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose
Cmax - the maximum observed plasma concentration (multiple dose)
Time frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
Effect of age on the BIA 6-512 pharmacokinetics
AUCτ - the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (multiple dose)
Time frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
Effect of age on the BIA 6-512 pharmacokinetics
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (multiple dose)
Time frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).
Effect of age on the BIA 6-512 pharmacokinetics
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 30 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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 200 mg BIA 6-512 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Germany.
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 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 30 Mar 2017. 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 Germany. 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?
Cmax - the maximum observed plasma concentration (single dose) (time frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose). The study lists 6 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 30 Mar 2017.