ParkinsonPhase 1NCT02305277

Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers

A Phase 1 study testing BIA 9-1067 (clinical micronized, CM) and BIA 9-1067 (to-be-marketed, TBM) in people with Parkinson, run by Bial - Portela C S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson
What is being tested?: BIA 9-1067 (clinical micronized, CM) and BIA 9-1067 (to-be-marketed, TBM)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: No sites listed yet
Study dates: Mar 2014to Jun 2014
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

A signed and dated informed consent form before any study-specific screening procedure was performed;
Male or female subjects aged 18 to 45 years, inclusive;
Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
Negative tests for hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;

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Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
Non-smokers or ex-smokers for at least 3 months;
Able to participate, and willing to give written informed consent and comply with the study restrictions.
If female:
She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used 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 was the sole partner of that subject] for all the duration of the study;
She had a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each treatment period.

Who cannot join

Subjects who had a 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, or had a clinically relevant surgical history;
Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
Had a history of relevant atopy or drug hypersensitivity;
Had a history of alcoholism and/or drug abuse;
Consumed more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)];
Had a significant infection or known inflammatory process on screening or admission to each treatment period;

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Had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
Had used medicines within 2 weeks of admission to first period that could affect the safety or other study assessments, in the Investigator's opinion;
Had previously received opicapone;
Had used any investigational drug or participated in any clinical trial within 90 days 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;
Were vegetarians, vegans or had medical dietary restrictions;
Could not communicate reliably with the Investigator;
Were unlikely to co-operate with the requirements of the study;
Were unwilling or unable to give written informed consent;
If female:
She was pregnant or breast-feeding.

About this study

Conditions: Parkinson
Being tested: BIA 9-1067 (clinical micronized, CM), BIA 9-1067 (to-be-marketed, TBM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIA 9-1067 (clinical micronized, CM)Drug
Also called OPC, Opicapone
BIA 9-1067 (to-be-marketed, TBM)Drug
Also called OPC, Opicapone

Study groups in NCT02305277
Study group	Role	What they receive
BIA 9-1067 5 mg Sequence 1	Experimental	volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)
BIA 9-1067 25 mg Sequence 1	Experimental	volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)
BIA 9-1067 50 mg Sequence 1	Experimental	volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)
BIA 9-1067 5 mg Sequence 2	Experimental	volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)
BIA 9-1067 25 mg Sequence 2	Experimental	volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)
BIA 9-1067 50 mg Sequence 2	Experimental	volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed Receives: Drug: BIA 9-1067 (clinical micronized, CM); Drug: BIA 9-1067 (to-be-marketed, TBM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Plasma Concentration
Measured: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose

Secondary outcomes (2)

AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067
Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration
Measured: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose
Tmax - Time of Occurrence of Cmax
Measured: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jun 2014

First posted2 Dec 2014 (estimated)
Study startMar 2014
Primary completionJun 2014
Study completionJun 2014

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 ParkinsonStudies 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: Crossover
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02305277
Sponsor's protocol ID: BIA-91067-119
Status last verified: Mar 2025
First submitted: 28 Nov 2014
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
ClinicalTrials.gov ID: NCT02305277
Acronym / sponsor ID: BIA-91067-119
Conditions: Parkinson
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 2 Dec 2014 (estimated)
Results: Posted 17 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
BIA 9-1067 5 mg Sequence 1	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 25 mg Sequence 1	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 50 mg Sequence 1	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 5 mg Sequence 2	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 25 mg Sequence 2	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 50 mg Sequence 2	Experimental	Drug: BIA 9-1067 (clinical micronized, CM), Drug: BIA 9-1067 (to-be-marketed, TBM)volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation CM - clinical micronized TBM - to-be-marketed

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

A signed and dated informed consent form before any study-specific screening procedure was performed;
Male or female subjects aged 18 to 45 years, inclusive;
Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
Negative tests for hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;

Key exclusion criteria (18 listed)

Subjects who had a 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, or had a clinically relevant surgical history;
Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
Had a history of relevant atopy or drug hypersensitivity;
Had a history of alcoholism and/or drug abuse;
Consumed more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)];

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 (clinical micronized, CM)Also: OPC, Opicapone	Drug	BIA 9-1067 25 mg Sequence 1, BIA 9-1067 25 mg Sequence 2, BIA 9-1067 5 mg Sequence 1, BIA 9-1067 5 mg Sequence 2, BIA 9-1067 50 mg Sequence 1, BIA 9-1067 50 mg Sequence 2
BIA 9-1067 (to-be-marketed, TBM)Also: OPC, Opicapone	Drug	BIA 9-1067 25 mg Sequence 1, BIA 9-1067 25 mg Sequence 2, BIA 9-1067 5 mg Sequence 1, BIA 9-1067 5 mg Sequence 2, BIA 9-1067 50 mg Sequence 1, BIA 9-1067 50 mg Sequence 2

Primary outcome

Cmax - Maximum Observed Plasma Concentration
Time frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose

2 secondary outcomes

AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067
Time frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose
Tmax - Time of Occurrence of Cmax
Time frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose

Results and safety

Results posted to the registry on 17 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIA 9-1067 5 mg Sequence 1	15	14
BIA 9-1067 25 mg Sequence 1	14	14
BIA 9-1067 50 mg Sequence 1	14	14
BIA 9-1067 5 mg Sequence 2	14	14
BIA 9-1067 25 mg Sequence 2	14	13
BIA 9-1067 50 mg Sequence 2	14	14

Primary outcome: Cmax - Maximum Observed Plasma Concentration

Time frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose. Mean (Standard Deviation). Unit: ng/mL

Measure	BIA 9-1067 5 mg CM n = 29	BIA 9-1067 5 mg TBM n = 28	BIA 9-1067 25 mg CM n = 28	BIA 9-1067 25 mg TBM n = 28	BIA 9-1067 50 mg CM n = 28	BIA 9-1067 50 mg TBM n = 28
Value	107.3 (55.7)	95.5 (37.8)	424.5 (155.7)	471.0 (206.9)	756.2 (302.4)	802.9 (363.0)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIA 9-1067 5 mg CM	0 of 29 (0%)	1 of 29 (3.4%)	Not reported
BIA 9-1067 5 mg TBM	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
BIA 9-1067 25 mg CM	1 of 28 (3.6%)	6 of 28 (21.4%)	Not reported
BIA 9-1067 25 mg TBM	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
BIA 9-1067 50 mg CM	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
BIA 9-1067 50 mg TBM	0 of 28 (0%)	3 of 28 (10.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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.

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 BIA 9-1067 (clinical micronized, CM) and BIA 9-1067 (to-be-marketed, TBM) in people with Parkinson, 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 12 inclusion and 18 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 12 Mar 2025. 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?

Yes. Results are posted in the registry (first posted 17 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 Observed Plasma Concentration (time frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305277.

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 12 Mar 2025.