Parkinson DiseasePhase 1NCT02305316
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
A Phase 1 study testing BIA 9-1067 non-micronized and BIA 9-1067 micronized in people with Parkinson Disease, run by Bial - Portela C S.A..
Trial summary
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. 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 non-micronized and BIA 9-1067 micronized
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Mar 2014
- 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
- A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,
- Male or female subjects aged 18 to 45 years, inclusive,
- Body mass index (BMI) between 19 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 on D-1 of each treatment period,
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- Negative screen for alcohol and drugs of abuse at screening and on D-1 of each treatment period,
- Non-smokers or ex-smokers for at least 3 months,
- Volunteer able to participate, and willing to give written informed consent and comply with the study restrictions,
- If female:
- Was not of childbearing potential by reason of surgery or, if of childbearing potential, uses 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 on D-1 of each treatment 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 clinically relevant abnormality in the coagulation tests,
- Any clinically relevant abnormality in the liver function tests,
- History of relevant atopy or drug hypersensitivity,
- History of alcoholism and/or drug abuse,
- 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°)],
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- 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,
- Previously received opicapone,
- Involvement in other clinical trials of any type within 90 days prior to screening,
- Participation in more than 2 clinical trials within the 12 months prior to screening,
- Blood donation or received any blood transfusion or any blood products within the 3 months prior to screening,
- Vegetarian, vegan or had medical dietary restrictions,
- Subject not able to communicate 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:
- Pregnant or breast-feeding,
- If of childbearing potential, a positive serum pregnancy test,
- Volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,
About this study
Official title: Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.
Read the detailed description
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067 non-micronized, BIA 9-1067 micronized
- 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 9-1067 non-micronizedDrug
Also called OPC, Opicapone
BIA 9-1067 micronizedDrug
Also called OPC, Opicapone
| Study group | Role | What they receive |
|---|---|---|
| BIA 9-1067 non-micronized - micronized | Experimental | Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized Receives: Drug: BIA 9-1067 non-micronized; Drug: BIA 9-1067 micronized |
| BIA 9-1067 micronized - non-micronized | Experimental | Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized Receives: Drug: BIA 9-1067 non-micronized; Drug: BIA 9-1067 micronized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Plasma Concentration
Maximum observed plasma concentration of BIA 9-1067
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Secondary outcomes (3)
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration
AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Tmax - Time of Occurrence of Cmax of BIA 9-1067
tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity
AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC 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 startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
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
- 28 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
- NCT02305316
- Sponsor's protocol ID
- BIA-91067-120
- Status last verified
- Jul 2015
- First submitted
- 28 Nov 2014
- Last updated
- 21 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 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02305316
- Acronym / sponsor ID
- BIA-91067-120
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Posted 21 Aug 2015
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, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.
Detailed description
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIA 9-1067 non-micronized - micronized | Experimental | Drug: BIA 9-1067 non-micronized, Drug: BIA 9-1067 micronizedEach subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized |
| BIA 9-1067 micronized - non-micronized | Experimental | Drug: BIA 9-1067 non-micronized, Drug: BIA 9-1067 micronizedEach subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,
- Male or female subjects aged 18 to 45 years, inclusive,
- Body mass index (BMI) between 19 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 (21 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 clinically relevant abnormality in the coagulation tests,
- Any clinically relevant abnormality in the liver function tests,
- History of relevant atopy or drug hypersensitivity,
- History of alcoholism and/or drug abuse,
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 9-1067 non-micronizedAlso: OPC, Opicapone | Drug | BIA 9-1067 micronized - non-micronized, BIA 9-1067 non-micronized - micronized |
| BIA 9-1067 micronizedAlso: OPC, Opicapone | Drug | BIA 9-1067 micronized - non-micronized, BIA 9-1067 non-micronized - micronized |
Primary outcome
Cmax - Maximum Observed Plasma Concentration
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Maximum observed plasma concentration of BIA 9-1067
3 secondary outcomes
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Tmax - Time of Occurrence of Cmax of BIA 9-1067
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
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 non-micronized and BIA 9-1067 micronized in people with Parkinson 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 12 inclusion and 21 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 21 Aug 2015. 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?
Yes. Results are posted in the registry (first posted 21 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 Concentration (time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC 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 21 Aug 2015.