Parkinson DiseasePhase 1NCT01532141
Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
A Phase 1 study testing BIA 9-1067 and Rasagiline in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in France.
Trial summary
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BIA 9-1067 and Rasagiline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who were able and willing to give written informed consent.
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- Subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
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- Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
- Subjects who were non-smokers or ex-smokers for at least 3 months.
- (If female) 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 or intrauterine device.
- (If female) She had a negative pregnancy test (β-HCG) at screening and admission to each treatment period
Who cannot join
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had any significant abnormality in the coagulation tests.
- Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion).
- Subjects who had a history of relevant atopy or drug hypersensitivity.
- Subjects who had a history of alcoholism or drug abuse.
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- Subjects who consumed more than 14 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period.
- Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
- Subjects who had received fluoxetine within 5 weeks of admission to the first period.
- Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion.
- Subjects who had previously received BIA 9-1067.
- Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
- Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
- Subjects who were vegetarians, vegans or have medical dietary restrictions.
- Subjects who could not communicated reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
- (If female) She was pregnant or breast-feeding.
- (If female) She was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device) or she uses oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.
Read the detailed description
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067, Rasagiline
- Keywords
- Parkinson Disease, BIA 9-1067
- 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 9-1067Drug
Also called OPC, Opicapone
50 mg BIA 9-1067 (single-dose)
RasagilineDrug
Also called Azilect®
1 mg rasagiline (single-dose)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Receives: Drug: BIA 9-1067; Drug: Rasagiline |
| Group 2 | Experimental | Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Receives: Drug: BIA 9-1067; Drug: Rasagiline |
| Group 3 | Experimental | Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone Receives: Drug: BIA 9-1067; Drug: Rasagiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Plasma Drug Concentration
Measured: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Secondary outcomes (2)
Time of Occurrence of Cmax (Tmax)
6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers
Measured: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Measured: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- 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
- Investigators
- Béatrice Astruc, MD, Principal investigator, Biotrial - Human Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532141
- Sponsor's protocol ID
- BIA-91067-113
- Status last verified
- Jul 2015
- First submitted
- 23 Jan 2012
- Last updated
- 20 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01532141
- Acronym / sponsor ID
- BIA-91067-113
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, BIA 9-1067
- 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
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Posted 20 Aug 2015
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 investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.
Detailed description
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BIA 9-1067, Drug: RasagilinePeriod 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg |
| Group 2 | Experimental | Drug: BIA 9-1067, Drug: RasagilinePeriod 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg |
| Group 3 | Experimental | Drug: BIA 9-1067, Drug: RasagilinePeriod 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects who were able and willing to give written informed consent.
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Key exclusion criteria (20 listed)
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had any significant abnormality in the coagulation tests.
- Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion).
- Subjects who had a history of relevant atopy or drug hypersensitivity.
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 9-1067Also: OPC, Opicapone50 mg BIA 9-1067 (single-dose) | Drug | Group 1, Group 2, Group 3 |
| RasagilineAlso: Azilect®1 mg rasagiline (single-dose) | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Cmax - Maximum Observed Plasma Drug Concentration
Time frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
2 secondary outcomes
Time of Occurrence of Cmax (Tmax)
Time frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Time frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Béatrice Astruc, MD principal investigator
Biotrial - Human Pharmacology Unit
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 9-1067 and Rasagiline in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in France.
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 20 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 20 Aug 2015. 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 France. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 - Maximum Observed Plasma Drug Concentration (time frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose). 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 20 Aug 2015.