Parkinson's DiseasePhase 1NCT02305030
Effect of Opicapone at Steady State on Warfarin Pharmacokinetics
A Phase 1 study testing BIA 9-1067 and Warfarin in people with Parkinson's Disease, run by Bial - Portela C S.A..
Trial summary
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BIA 9-1067 and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2014
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A signed and dated informed consent form before any study-specific screening procedure was performed,
- Male or female subjects aged 18 to 45 years, inclusive,
- Body mass index (BMI) between 18 and 30 kg/m2,
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG),
- Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
- Clinical laboratory test results clinically acceptable at screening and at admission to each inpatient period,
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- Negative screen for alcohol and drugs of abuse at screening and at admission to each inpatient period,
- Non-smokers or ex-smokers for at least 3 months,
- Able to participate, and willing to give written informed consent and comply with the study restrictions,
- Able to swallow a high number of capsules within a short time frame,
- If female:
- Was not of childbearing potential by reason of surgery or, if of childbearing potential, used an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for the entire duration of the study,
- Negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each inpatient period.
Who cannot join
- Any 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, or had a clinically relevant surgical history,
- Any personal or family history of haemostatic disorder,
- Any personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis,
- Any clinically relevant findings in the laboratory tests, particularly any abnormality in the coagulation tests or the liver function tests,
- History of relevant atopy or drug hypersensitivity,
- History of alcoholism and/or drug abuse,
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- Current consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)],
- Any significant infection or known inflammatory process on screening or admission to each treatment period; any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,
- Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion, or intake of any of the prohibited medications (i.e., CYP2C9 inhibitor taken within 1 week prior to start of administration of study drug, and CYP2C9 inducer taken within 4 weeks prior to dosing),
- Previous use of opicapone,
- Use of any investigational drug or participation in any clinical trial within 3 months prior to screening; participation in more than 2 clinical trials within the 12 months prior to screening,
- Blood donation or receipt of any blood transfusion or any blood products within the 3 months prior to screening,
- Vegetarian, vegan or had medical dietary restrictions,
- Not able to communicate reliably with the investigator,
- Unlikely to co-operate with the requirements of the study,
- Unwilling or unable to give written informed consent,
- CYP2C9 poor metaboliser, as assessed by genotyping,
- If female:
- Pregnant or breast-feeding.
About this study
Official title: Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days.
Read the detailed description
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50 mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose of 25 mg warfarin.
- Conditions
- Parkinson's Disease
- Being tested
- BIA 9-1067, Warfarin
- 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
WarfarinDrug
Also called Uniwarfin
| Study group | Role | What they receive |
|---|---|---|
| BIA 9-1067 / Warfarin | Experimental | BIA 9-1067 capsules of 25 mg or 50 mg Warfarin capsules of 5 mg Receives: Drug: BIA 9-1067; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
R- and S-warfarin plasma concentration
Measured: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post-warfarin
Secondary outcomes (2)
Opicapone plasma concentration
Measured: D1 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, and 8 h post-opicapone dose
BIA 9-1103 (sulphate metabolite) plasma concentration
Measured: D1 pre-dose and from D5 to D7 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, 8, 24, 48, 72 and 144 h post-opicapone dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02305030
- Sponsor's protocol ID
- BIA-91067-127
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02305030
- Acronym / sponsor ID
- BIA-91067-127
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Dec 2014 (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.
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days.
Detailed description
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50 mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose of 25 mg warfarin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIA 9-1067 / Warfarin | Experimental | Drug: BIA 9-1067, Drug: WarfarinBIA 9-1067 capsules of 25 mg or 50 mg Warfarin capsules of 5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- A signed and dated informed consent form before any study-specific screening procedure was performed,
- Male or female subjects aged 18 to 45 years, inclusive,
- Body mass index (BMI) between 18 and 30 kg/m2,
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG),
- Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
Key exclusion criteria (19 listed)
- Any 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, or had a clinically relevant surgical history,
- Any personal or family history of haemostatic disorder,
- Any personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis,
- Any clinically relevant findings in the laboratory tests, particularly any abnormality in the coagulation tests or the liver function tests,
- 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, Opicapone | Drug | BIA 9-1067 / Warfarin |
| WarfarinAlso: Uniwarfin | Drug | BIA 9-1067 / Warfarin |
Primary outcome
R- and S-warfarin plasma concentration
Time frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post-warfarin
2 secondary outcomes
Opicapone plasma concentration
Time frame: D1 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, and 8 h post-opicapone dose
BIA 9-1103 (sulphate metabolite) plasma concentration
Time frame: D1 pre-dose and from D5 to D7 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, 8, 24, 48, 72 and 144 h post-opicapone 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 2 Dec 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIA 9-1067 and Warfarin in people with Parkinson's Disease, run by Bial - Portela C S.A..
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 13 inclusion and 19 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
R- and S-warfarin plasma concentration (time frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post-warfarin). 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 2 Dec 2014.