Parkinson DiseasePhase 1NCT01533116
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
A Phase 1 study testing BIA 9-1067, levodopa/carbidopa and levodopa/benserazide in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Canada.
Trial summary
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BIA 9-1067, levodopa/carbidopa and levodopa/benserazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Mar 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 25 to 45 years
- All sexes
- 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 prior to participation in the study.
- Male or female volunteers.
- Volunteers of at least 25 years of age but not older than 45 years.
- Volunteers with body mass index (BMI) greater than or equal to 19 and below 30 kg/m2.
- Volunteers who were healthy as determined by pre-study (at screening) medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Volunteers who had clinical laboratory test results judged clinically acceptable (within the laboratory's stated normal range; if not within this range, they must had been without any clinical significance) at screening and admission to first treatment period.
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- Volunteers who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
- Volunteers who had negative screen of ethyl alcohol and drugs of abuse at screening and admission to the treatment period.
- Volunteers who were non- or ex-smokers. For the purpose of this study, an ex-smoker is defined as someone who completely stopped smoking for at least 3 months before day 1 of this study.
- Due to unknown risks and potential harm to the unborn fetus, sexually active men or women must have agreed to use a medically acceptable form of contraception throughout the study.
- If female of childbearing potential, she had a negative HCG beta serum pregnancy test at screening and admission to each treatment period.
- The informed consent form must have been signed by all volunteers, prior to their participation in the study.
Who cannot join
- Volunteers who did not conform to the above inclusion criteria, or in case of
- Volunteers who had a clinically relevant surgical history.
- Volunteers who had a clinically relevant family history.
- Volunteers who had a history of relevant atopy.
- Volunteers who had a significant infection or known inflammatory process at screening or admission to the treatment period.
- Volunteers who had acute gastrointestinal symptoms at the time of screening or admission to the treatment period (e.g., nausea, vomiting, diarrhoea, heartburn).
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- Volunteers who were vegetarians, vegans or have medical dietary restrictions.
- Volunteers who could not communicate reliably with the investigator.
- Volunteers who were unlikely to co-operate with the requirements of the study.
- History of hypersensitivity to BIA 9-1067, tolcapone, entacapone, levodopa, benserazide 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, lymphatic, musculoskeletal, genitourinary, 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.
- Presence of suspicious undiagnosed skin lesions or a history of melanoma.
- Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis.
- History of significant glaucoma.
- Used of prescription medications including monoamine oxidase (MAO) inhibitors within 28 days before day 1 of the study.
- Used of over-the-counter (OTC) products within 7 days before day 1 of the study.
- Maintenance therapy with any drug, or significant history of drug dependency (drug abuse) 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.
- 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 ethyl alcohol or drugs of abuse at admission to the treatment period.
- Any history of tuberculosis and/or prophylaxis for tuberculosis.
- Positive results to HIV, HBsAg or anti-HCV tests.
- Participation in any previous clinical study with BIA 9-1067.
- Females who were pregnant according to a positive serum pregnancy test or were lactating.
- Females of childbearing potential who refused to use an acceptable contraceptive regimen throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics
Read the detailed description
Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of healthy subjects
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067, Placebo, levodopa/carbidopa, levodopa/benserazide
- 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
PlaceboDrug
Also called PLC, Placebo
levodopa/carbidopaDrug
Also called Sinemet® 100/25
levodopa/benserazideDrug
Also called Prolopa® 100/25
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BIA 9-1067 | Experimental | 5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 Receives: Drug: BIA 9-1067; Drug: levodopa/carbidopa; Drug: levodopa/benserazide |
| Placebo | Experimental | Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28. Receives: Drug: Placebo; Drug: levodopa/carbidopa; Drug: levodopa/benserazide |
| 15 mg BIA 9-1067 | Experimental | 15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 Receives: Drug: BIA 9-1067; Drug: levodopa/carbidopa; Drug: levodopa/benserazide |
| 30 mg BIA 9-1067 | Experimental | 30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 Receives: Drug: BIA 9-1067; Drug: levodopa/carbidopa; Drug: levodopa/benserazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Plasma Concentration
Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Tmax - Time to Maximum Plasma Concentration
Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity
tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose
AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionMar 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 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
- NCT01533116
- Sponsor's protocol ID
- BIA-91067-118
- Status last verified
- Oct 2015
- First submitted
- 24 Jan 2012
- Last updated
- 16 Nov 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 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01533116
- Acronym / sponsor ID
- BIA-91067-118
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, BIA 9-1067
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 16 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics
Detailed description
Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg BIA 9-1067 | Experimental | Drug: BIA 9-1067, Drug: levodopa/carbidopa, Drug: levodopa/benserazide5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 |
| Placebo | Experimental | Drug: Placebo, Drug: levodopa/carbidopa, Drug: levodopa/benserazidePlacebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28. |
| 15 mg BIA 9-1067 | Experimental | Drug: BIA 9-1067, Drug: levodopa/carbidopa, Drug: levodopa/benserazide15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 |
| 30 mg BIA 9-1067 | Experimental | Drug: BIA 9-1067, Drug: levodopa/carbidopa, Drug: levodopa/benserazide30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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 prior to participation in the study.
- Male or female volunteers.
- Volunteers of at least 25 years of age but not older than 45 years.
- Volunteers with body mass index (BMI) greater than or equal to 19 and below 30 kg/m2.
- Volunteers who were healthy as determined by pre-study (at screening) medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Key exclusion criteria (31 listed)
- Volunteers who did not conform to the above inclusion criteria, or in case of
- Volunteers who had a clinically relevant surgical history.
- Volunteers who had a clinically relevant family history.
- Volunteers who had a history of relevant atopy.
- Volunteers who had a significant infection or known inflammatory process at screening or admission to the treatment period.
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 | 15 mg BIA 9-1067, 30 mg BIA 9-1067, 5 mg BIA 9-1067 |
| PlaceboAlso: PLC, Placebo | Drug | Placebo |
| levodopa/carbidopaAlso: Sinemet® 100/25 | Drug | 15 mg BIA 9-1067, 30 mg BIA 9-1067, 5 mg BIA 9-1067, Placebo |
| levodopa/benserazideAlso: Prolopa® 100/25 | Drug | 15 mg BIA 9-1067, 30 mg BIA 9-1067, 5 mg BIA 9-1067, Placebo |
Primary outcome
Cmax - Maximum Plasma Concentration
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Tmax - Time to Maximum Plasma Concentration
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase
AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
AUEC0-24 - Area under the effect-time curve (AUEC) to 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 16 Nov 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, levodopa/carbidopa and levodopa/benserazide in people with Parkinson Disease, 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 12 inclusion and 31 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 16 Nov 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 16 Nov 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 Plasma Concentration (time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h). The study lists 5 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 16 Nov 2015.