Parkinson DiseasePhase 1NCT02092168
Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young 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 is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BIA 9-1067
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jan 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects (young and elderly):
- A signed and dated informed consent form before any study-specific screening procedure is performed.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
- Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Had to be able to abstain from smoking during the inpatient stay.
- With a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Young subjects only:
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- Males aged between 18 and 40 years, inclusive.
- Elderly subjects only:
- Males older than 65 years, inclusive.
Who cannot join
- All subjects (young and elderly):
- General
- Subjects who had participated in a clinical trial with an investigational drug within the 90 days prior to screening.
- Subjects who were likely to be noncompliant with the protocol, or who were felt to be unsuitable by the Investigator for any other reason.
- 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 (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-ethylenedioxymethamphetamine; ecstasy]).
Show all 23Show fewer
- Medical History
- Any significant cardiovascular, hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes,), immunological, dermatological, haematological, neurological, or psychiatric disease and history thereof.
- 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).
- History of any clinically important drug allergy.
- Had previously received BIA 9-1067.
- Prohibited treatments and dietary restrictions
- 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.
- Young subjects only:
- Prohibited treatments and dietary restrictions
- Prohibited Treatments: use of any investigational drug within 90 days (young and elderly subjects) or prescription drug within 30 days before investigational medical product (IMP) administration.
- Elderly subjects only:
- Prohibited treatments and dietary restrictions
- For elderly subjects, previously prescribed medications that do not interfere with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 9-1067 and adrenal or renal function were allowed if the dose regimen had been stable for at least 4 weeks and was expected to remain stable throughout the study. Such concomitant medications was reviewed and mutually agreed upon by the sponsor and the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects
The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.
Read the detailed description
Methodology:
Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects.
Duration of treatment:
Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inpatient period, a 12 day inpatient period and an end of study visit (ESV) 7 to 10 days after the discharge from the Unit.
The study design followed the recommendations of the CPMP/ICH/379/95 (ICH Topic E7) Note for Guidance on Studies in Support of Special Populations: Geriatrics, namely in the inclusion of subjects aged 65 years or older and contemplating single-dose and steady-state PK profiles. As the primary endpoint of the study was to characterize the pharmacokinetic profile of BIA 9-1067 and its metabolites in different parallel groups, there was no need to implement blinding procedures or to include a control group. Consequently, the trial was an open label study. Healthy subjects rather than patients with Parkinson's disease have been chosen as the study population, due to the lack of over-toxicity of the drug and an acceptable risk-benefit ratio. This allowed for a better interpretation of the study results, as there were no confounding factors resulting from changes in disease state and or concomitant medications.
The subjects were given a screening number after signing the informed consent by chronological order of inclusion in each group (young/elderly).
- Conditions
- Parkinson Disease
- Being tested
- BIA 9-1067
- Keywords
- Opicapone, BIAL
- 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 Opicapone, OPC
| Study group | Role | What they receive |
|---|---|---|
| BIA 9-1067 30 mg (once daily) - Elderly Subjects | Experimental | BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. Receives: Drug: BIA 9-1067 |
| BIA 9-1067 30 mg (once daily) - Young Subjects | Experimental | BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. Receives: Drug: BIA 9-1067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Plasma Concentration
Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067
Measured: Day 1 and Day 7
Tmax - Time to Reach Cmax
Tmax - Time to reach maximum plasma concentration of BIA 9-1067
Measured: Day 1 and Day 7
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrício SOARES-DA-SILVA, MD, PhD, Study director, BIAL - Portela & Ca S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092168
- Sponsor's protocol ID
- BIA-91067-105
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2012
- Last updated
- 14 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 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects
- ClinicalTrials.gov ID
- NCT02092168
- Acronym / sponsor ID
- BIA-91067-105
- Conditions
- Parkinson Disease
- Keywords
- Opicapone, BIAL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 14 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 is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.
Detailed description
Methodology:
Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects.
Duration of treatment:
Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inpatient period, a 12 day inpatient period and an end of study visit (ESV) 7 to 10 days after the discharge from the Unit.
The study design followed the recommendations of the CPMP/ICH/379/95 (ICH Topic E7) Note for Guidance on Studies in Support of Special Populations: Geriatrics, namely in the inclusion of subjects aged 65 years or older and contemplating single-dose and steady-state PK profiles. As the primary endpoint of the study was to characterize the pharmacokinetic profile of BIA 9-1067 and its metabolites in different parallel groups, there was no need to implement blinding procedures or to include a control group. Consequently, the trial was an open label study. Healthy subjects rather than patients with Parkinson's disease have been chosen as the study population, due to the lack of over-toxicity of the drug and an acceptable risk-benefit ratio. This allowed for a better interpretation of the study results, as there were no confounding factors resulting from changes in disease state and or concomitant medications.
The subjects were given a screening number after signing the informed consent by chronological order of inclusion in each group (young/elderly).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIA 9-1067 30 mg (once daily) - Elderly Subjects | Experimental | Drug: BIA 9-1067BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. |
| BIA 9-1067 30 mg (once daily) - Young Subjects | Experimental | Drug: BIA 9-1067BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A signed and dated informed consent form before any study-specific screening procedure is performed.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
- Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Had to be able to abstain from smoking during the inpatient stay.
- With a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Males aged between 18 and 40 years, inclusive.
Key exclusion criteria (23 listed)
- General
- Subjects who had participated in a clinical trial with an investigational drug within the 90 days prior to screening.
- Subjects who were likely to be noncompliant with the protocol, or who were felt to be unsuitable by the Investigator for any other reason.
- 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 (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-ethylenedioxymethamphetamine; ecstasy]).
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: Opicapone, OPC | Drug | BIA 9-1067 30 mg (once daily) - Elderly Subjects, BIA 9-1067 30 mg (once daily) - Young Subjects |
Primary outcome
Cmax - Maximum Plasma Concentration
Time frame: Day 1 and Day 7
Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067
Tmax - Time to Reach Cmax
Time frame: Day 1 and Day 7
Tmax - Time to reach maximum plasma concentration of BIA 9-1067
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Time frame: Day 1 and Day 7
AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
Patrício SOARES-DA-SILVA, MD, PhD study director
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 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 9 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 14 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. 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 14 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?
Cmax - Maximum Plasma Concentration (time frame: Day 1 and Day 7). The study lists 3 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 14 Jan 2015.