Parkinson DiseasePhase 1NCT01520727
A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
A Phase 1 study testing BIA 9-1067 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in France.
Trial summary
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses. 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 Disease
- What is being tested?
- BIA 9-1067
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Apr 2009
- 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
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Who cannot join
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
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- History of any clinically important drug allergy.
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- Donation of blood (i.e. 450 mL) within 60 days before study day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.
Read the detailed description
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067, Placebo
- Keywords
- 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 Entacapone
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
PlaceboDrug
single-dose
| Study group | Role | What they receive |
|---|---|---|
| BIA 9-1067 10 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 10 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 25 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 25 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 50 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 50 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 100 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 100 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 200 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 200 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 400 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 400 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 800 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 800 mg Receives: Drug: BIA 9-1067 |
| BIA 9-1067 1200 mg | Experimental | BIA 9-1067 (Opicapone, OPC) - 1200 mg Receives: Drug: BIA 9-1067 |
| Placebo | Placebo comparator | Placebo (PLC): single-dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Safety was evaluated from the number of reported adverse events (AEs)
Measured: 7 weeks
Secondary outcomes (2)
Cmax - BIA 9-1067
Cmax - maximum plasma concentration
Measured: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Time to Cmax (Tmax)
Measured: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionApr 2009
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Fauchoux, MD, Principal investigator, Biotrial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520727
- Sponsor's protocol ID
- BIA-91067-101
- Status last verified
- Dec 2014
- First submitted
- 18 Jan 2012
- Last updated
- 8 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 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01520727
- Acronym / sponsor ID
- BIA-91067-101
- Conditions
- Parkinson Disease
- Keywords
- BIA 9-1067
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 8 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 purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.
Detailed description
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| BIA 9-1067 10 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 10 mg |
| BIA 9-1067 25 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 25 mg |
| BIA 9-1067 50 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 50 mg |
| BIA 9-1067 100 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 100 mg |
| BIA 9-1067 200 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 200 mg |
| BIA 9-1067 400 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 400 mg |
| BIA 9-1067 800 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 800 mg |
| BIA 9-1067 1200 mg | Experimental | Drug: BIA 9-1067BIA 9-1067 (Opicapone, OPC) - 1200 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (PLC): single-dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Key exclusion criteria (11 listed)
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
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: Entacaponesingle ascending doses in up to 8 sequential groups of 8 healthy young male subjects | Drug | BIA 9-1067 10 mg, BIA 9-1067 100 mg, BIA 9-1067 1200 mg, BIA 9-1067 200 mg, BIA 9-1067 25 mg, BIA 9-1067 400 mg, BIA 9-1067 50 mg, BIA 9-1067 800 mg |
| Placebosingle-dose | Drug | Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: 7 weeks
Safety was evaluated from the number of reported adverse events (AEs)
2 secondary outcomes
Cmax - BIA 9-1067
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Time to Cmax (Tmax)
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Nicolas Fauchoux, MD principal investigator
Biotrial
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 Disease, run by Bial - Portela C S.A. at 1 site in France.
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 4 inclusion and 11 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 8 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 France. 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 8 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?
Adverse Events (AEs) (time frame: 7 weeks). 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 8 Jan 2015.