ParkinsonPhase 1NCT02071823
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
A Phase 1 study testing BIA 9-1067 in people with Parkinson, run by Bial - Portela C S.A. at 1 site in Canada.
Trial summary
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- BIA 9-1067
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Jun 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
- Male volunteer
- Volunteer aged of at least 18 years but not older than 45 years
- Volunteer with a body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Healthy according to the medical history, laboratory results and physical examination
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study
- The informed consent form must be signed by all volunteers, prior to their participation in the study.
Who cannot join
- Volunteers presenting any of the following will not be included in the study:Significant history of hypersensitivity to any catechol-structured drugs (e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamide) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic, dermatologic or connective tissue disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Presence of significant heart disease or disorder according to ECG
Show all 18Show fewer
- Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis
- Pheochromocytoma due to the increased risk of hypertensive crisis
- Use of MAO inhibitors within 14 days of day 1 of the study
- Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study
- Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
- Positive urine screening of drugs of abuse
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive results to HIV, HBsAg or anti-HCV tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules in Healthy Male Volunteers Following Administration of a 50 mg Dose / Fasted and Fed States
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.
Read the detailed description
Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.
- Conditions
- Parkinson
- Being tested
- BIA 9-1067
- Keywords
- Opicapone,, Parkinson,, Bial,, BIA 9-1067
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 9-1067Drug
Also called Opicapone, OPC
A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A Fed/Fasted | Experimental | A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted Receives: Drug: BIA 9-1067 |
| Group B Fasted/Fed | Experimental | A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed Receives: Drug: BIA 9-1067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Plasma Concentration
Cmax - Maximum observed plasma concentration of BIA 9-1067
Measured: Day 1
AUCt - Cumulative Area Under the Plasma Concentration Time Curve
AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067
Measured: Day 1
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 2008
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 ParkinsonStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071823
- Sponsor's protocol ID
- BIA-91067-104
- Status last verified
- Dec 2014
- First submitted
- 19 Jan 2012
- Last updated
- 9 Jan 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 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Crossover Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules in Healthy Male Volunteers Following Administration of a 50 mg Dose / Fasted and Fed States
- ClinicalTrials.gov ID
- NCT02071823
- Acronym / sponsor ID
- BIA-91067-104
- Conditions
- Parkinson
- Keywords
- Opicapone,, Parkinson,, Bial,, BIA 9-1067
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.
Detailed description
Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Fed/Fasted | Experimental | Drug: BIA 9-1067A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on: Period 1: Fed Washout Period (7days) Period 2: Fasted |
| Group B Fasted/Fed | Experimental | Drug: BIA 9-1067A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on: Period 1: Fasted Washout Period (7days) Period 2: Fed |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
- Male volunteer
- Volunteer aged of at least 18 years but not older than 45 years
- Volunteer with a body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
Key exclusion criteria (18 listed)
- Volunteers presenting any of the following will not be included in the study:Significant history of hypersensitivity to any catechol-structured drugs (e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamide) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic, dermatologic or connective tissue disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
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: Opicapone, OPCA single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days. | Drug | Group A Fed/Fasted, Group B Fasted/Fed |
Primary outcome
Cmax - Maximum Observed Plasma Concentration
Time frame: Day 1
Cmax - Maximum observed plasma concentration of BIA 9-1067
AUCt - Cumulative Area Under the Plasma Concentration Time Curve
Time frame: Day 1
AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)
Time frame: Day 1
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Eric Sicard, MD principal investigator
Algorithme Pharma Inc
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 in people with Parkinson, run by Bial - Portela C S.A. at 1 site in Canada.
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 8 inclusion and 18 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 9 Jan 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 Canada. 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 9 Jan 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 Concentration (time frame: Day 1). The study lists 3 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 9 Jan 2015.