Parkinson DiseasePhase 1NCT03116308
Effect of Food on Opicapone
A Phase 1 study testing Opicapone (OPC) in people with Parkinson Disease, run by Bial - Portela C S.A..
Trial summary
The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses. 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?
- Opicapone (OPC)
- 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
- 21 Nov 2014to 28 Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 and to comply with the study restrictions.
- Male or female subjects aged between 18 and 45 years, inclusive.
- 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-HCV Ab and HIV-1 and HIV-2 Ab at screening.
- Clinical laboratory test results clinically acceptable at screening and admission.
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- Negative screen for alcohol and drugs of abuse at screening and admission.
- Non-smokers or ex-smokers for at least 3 months.
- If female:
- Not of childbearing potential by reason of surgery or, if of childbearing potential, she 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 is the sole partner of that subject) for all the duration of the study.
- Negative serum pregnancy test at screening and a negative urine pregnancy test on admission.
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.
- Clinically relevant abnormality in the coagulation tests.
- Clinically relevant abnormality in the liver function tests.
- History of relevant atopy or drug hypersensitivity, particularly to any COMT inhibitor.
- History of alcoholism or drug abuse.
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- Consume more than 14 units of alcohol a week.
- Significant infection or known inflammatory process at screening or admission.
- Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.
- Used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.
- Previously received OPC.
- Used any investigational drug or participated in any clinical trial within 90 days prior to screening.
- Participated in more than 2 clinical trials within the 12 months prior to screening.
- Donated or received any blood or blood products within the 3 months prior to screening.
- Vegetarians, vegans or have medical dietary restrictions.
- Cannot communicate reliably with the investigator.
- Unlikely to co-operate with the requirements of the study.
- If female:
- Pregnant or breast-feeding.
- Of childbearing potential and not used an approved effective contraceptive method or she uses oral contraceptives.
About this study
Official title: Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.
Read the detailed description
Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening administration after 2 hours fast).
- Conditions
- Parkinson Disease
- Being tested
- Opicapone (OPC)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opicapone (OPC)Drug
Also called Ongentys, BIA 9-1067
50 mg OPC capsules; oral route
| Study group | Role | What they receive |
|---|---|---|
| 50 mg OPC | Experimental | Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast) Receives: Drug: Opicapone (OPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time to occurrence of Emax (tEmax) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Area under the effect-time curve (AUEC) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Maximum observed effect on COMT activity (Emax) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time to occurrence of Emax (tEmax) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Area under the effect-time curve (AUEC) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary outcomes (4)
Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)
Pharmacokinetic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time of occurrence of Cmax (tmax) - Day 9 (fasted state)
Pharmacokinetic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Maximum observed plasma concentration (Cmax) - Day 10 (fed state)
Pharmacokinetic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time of occurrence of Cmax (tmax) - Day 10 (fed state)
Pharmacokinetic parameters for opicapone
Measured: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start21 Nov 2014
- Primary completion28 Jan 2015
- Study completion28 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- 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
- NCT03116308
- Sponsor's protocol ID
- BIA-91067-128
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03116308
- Acronym / sponsor ID
- BIA-91067-128
- 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
- 21 Nov 2014 (actual)
- Primary completion
- 28 Jan 2015 (actual)
- Study completion
- 28 Jan 2015 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
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 investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.
Detailed description
Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening administration after 2 hours fast).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 mg OPC | Experimental | Drug: Opicapone (OPC)Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able and willing to give written informed consent and to comply with the study restrictions.
- Male or female subjects aged between 18 and 45 years, inclusive.
- 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-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Key exclusion criteria (20 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.
- Clinically relevant abnormality in the coagulation tests.
- Clinically relevant abnormality in the liver function tests.
- History of relevant atopy or drug hypersensitivity, particularly to any COMT inhibitor.
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 |
|---|---|---|
| Opicapone (OPC)Also: Ongentys, BIA 9-106750 mg OPC capsules; oral route | Drug | 50 mg OPC |
Primary outcome
Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
Time to occurrence of Emax (tEmax) - Day 9 (fasted state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
Area under the effect-time curve (AUEC) - Day 9 (fasted state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
Maximum observed effect on COMT activity (Emax) - Day 10 (fed state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
Time to occurrence of Emax (tEmax) - Day 10 (fed state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
Area under the effect-time curve (AUEC) - Day 10 (fed state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Pharmacodynamic parameters for opicapone
4 secondary outcomes
Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time of occurrence of Cmax (tmax) - Day 9 (fasted state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Maximum observed plasma concentration (Cmax) - Day 10 (fed state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Time of occurrence of Cmax (tmax) - Day 10 (fed state)
Time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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 Opicapone (OPC) 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 11 inclusion and 20 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 17 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state) (time frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose). The study lists 6 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 17 Apr 2017.