Parkinson DiseasePhase 1NCT01519284
Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
A Phase 1 study testing BIA 9-1067 5 mg, Entacapone and levodopa/carbidopa in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone. 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 5 mg, Entacapone and levodopa/carbidopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2009to Jun 2011
- 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
- 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 19 and 30 kg/m2, inclusive.
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
- Clinical laboratory test results clinically acceptable at screening and admission to the treatment period.
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- Negative screen for alcohol and drugs of abuse at screening and admission to the treatment period.
- 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: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).
- (If female) She had a negative urine pregnancy test at screening and admission to the treatment period.
Who cannot join
- 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.
- Clinically relevant surgical history.
- Any abnormality in the coagulation tests.
- Any abnormality in the liver function tests.
- A history of relevant atopy or drug hypersensitivity.
- A history or presence of narrow-angle glaucoma.
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- A suspicious undiagnosed skin lesions or a history of melanoma.
- History of alcoholism or drug abuse.
- Consumed more than 14 units of alcohol a week.
- Significant infection or known inflammatory process at screening or admission to the treatment period.
- Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.
- Had used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.
- Had used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.
- Had previously received BIA 9-1067.
- Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
- Had participated in more than 2 clinical trials within the 12 months prior to screening.
- Had donated or received any blood or blood products within the 3 months prior to screening.
- Vegetarians, vegans or had medical dietary restrictions.
- Cannot communicate reliably with the investigator.
- Unlikely to co-operate with the requirements of the study.
- Unwilling or unable to gave 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 or she used oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Read the detailed description
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067 5 mg, Entacapone, Placebo, levodopa/carbidopa, BIA 9-1067 15 mg
- 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 9-1067 5 mgDrug
Also called OPC, Opicapone
BIA 9-1067 OPC, Opicapone 5 mg
EntacaponeDrug
Entacapone 200 mg
PlaceboDrug
Also called PLC, placebo
placebo (four times a day)
levodopa/carbidopaDrug
standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 15 mgDrug
Also called OPC, Opicapone
BIA 9-1067 OPC, Opicapone 15 mg
BIA 9-1067 30 mgDrug
Also called OPC, Opicapone
BIA 9-1067 OPC, Opicapone 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Placebo at all the dosing times Receives: Drug: Placebo |
| Group 2 | Experimental | Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose Receives: Drug: BIA 9-1067 5 mg; Drug: Placebo; Drug: levodopa/carbidopa |
| Group 3 | Experimental | Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose Receives: Drug: Placebo; Drug: levodopa/carbidopa; Drug: BIA 9-1067 15 mg |
| Group 4 | Experimental | Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose Receives: Drug: Placebo; Drug: levodopa/carbidopa; Drug: BIA 9-1067 30 mg |
| Group 5 | Experimental | Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose Receives: Drug: Entacapone; Drug: Placebo; Drug: levodopa/carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Plasma Concentration of Levodopa
Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Measured: 8 days
Secondary outcomes (3)
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.
Measured: 8 days
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.
AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Measured: 8 days
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionJun 2011
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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Vaz-da-Silva, MD, PhD, Principal investigator, BIAL - Portela & Cª S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519284
- Sponsor's protocol ID
- BIA-91067-114
- 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
- A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01519284
- Acronym / sponsor ID
- BIA-91067-114
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, BIA 9-1067
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jan 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.
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Detailed description
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: PlaceboPlacebo at all the dosing times |
| Group 2 | Experimental | Drug: BIA 9-1067 5 mg, Drug: Placebo, Drug: levodopa/carbidopaDay 1 to 7: BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose |
| Group 3 | Experimental | Drug: Placebo, Drug: levodopa/carbidopa, Drug: BIA 9-1067 15 mgDay 1 to 7: BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose |
| Group 4 | Experimental | Drug: Placebo, Drug: levodopa/carbidopa, Drug: BIA 9-1067 30 mgDay 1 to 7: BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose Day 8: BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose |
| Group 5 | Experimental | Drug: Entacapone, Drug: Placebo, Drug: levodopa/carbidopaDay 1 to 7: Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose Day 8: Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 19 and 30 kg/m2, inclusive.
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
Key exclusion criteria (23 listed)
- 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.
- Clinically relevant surgical history.
- Any abnormality in the coagulation tests.
- Any abnormality in the liver function tests.
- 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 9-1067 5 mgAlso: OPC, OpicaponeBIA 9-1067 OPC, Opicapone 5 mg | Drug | Group 2 |
| EntacaponeEntacapone 200 mg | Drug | Group 5 |
| PlaceboAlso: PLC, placeboplacebo (four times a day) | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
| levodopa/carbidopastandard release levodopa/carbidopa 100/25 mg (single-dose) | Drug | Group 2, Group 3, Group 4, Group 5 |
| BIA 9-1067 15 mgAlso: OPC, OpicaponeBIA 9-1067 OPC, Opicapone 15 mg | Drug | Group 3 |
| BIA 9-1067 30 mgAlso: OPC, OpicaponeBIA 9-1067 OPC, Opicapone 30 mg | Drug | Group 4 |
Primary outcome
Cmax - Maximum Plasma Concentration of Levodopa
Time frame: 8 days
Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
3 secondary outcomes
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
Time frame: 8 days
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.
Time frame: 8 days
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
Time frame: 8 days
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.
Manuel Vaz-da-Silva, MD, PhD principal investigator
BIAL - Portela & Cª S.A
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 5 mg, Entacapone and levodopa/carbidopa in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.
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 23 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 Portugal. 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. Some participants in this study may receive a placebo. 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 Plasma Concentration of Levodopa (time frame: 8 days). 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.