Parkinson's Disease (PD)Phase 1NCT02169466

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

A Phase 1 study testing BIA 9-1067 and Madopar® HBS in people with Parkinson's Disease (PD), run by Bial - Portela C S.A. at 1 site in Portugal.

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

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS). 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's Disease (PD)
What is being tested?: BIA 9-1067 and Madopar® HBS
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 sitePortugal
Study dates: Jan 2009to May 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

Male subjects between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.
Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.
Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.

Who cannot join

Subjects who did not conform to the above inclusion criteria, or
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.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity.

Show all 19Show fewer

Subjects who had a history of glaucoma.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 21 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or first admission.
Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans or have medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
Subjects who were BIAL - Portela \& Cª, SA employees.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
S. Mamede Do Coronado, Trofa, 4745-457

Other trials in Portugal

About this study

Official title: Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Read the detailed description

Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.

Conditions: Parkinson's Disease (PD)
Being tested: BIA 9-1067, Placebo, Madopar® HBS
Keywords: Parkinson's disease (PD), Opicapone, 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 OPC, Opicapone
OPC, Opicapone
PlaceboDrug
Also called PLC, Placebo
PLC, Placebo
Madopar® HBSDrug
controlled-release levodopa 100 mg/benserazide 25 mg

Study groups in NCT02169466
Study group	Role	What they receive
Group 1	Experimental	Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Madopar® HBS
Group 2	Experimental	Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Madopar® HBS
Group 3	Experimental	Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Madopar® HBS
Group 4	Experimental	Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Madopar® HBS

What is being measured

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

Cmax - Maximum Observed Plasma Concentration of Levodopa
Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
Measured: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
Measured: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-∞ - AUC From Time Zero to Infinity
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
Measured: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Tmax - Time to Cmax
Primary pharmacokinetic parameter: tmax - time to Cmax
Measured: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Timeline

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

Jan 2009May 2009

First posted23 Jun 2014 (estimated)
Study startJan 2009
Primary completionMay 2009
Study completionMay 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's Disease (PD)Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02169466
Sponsor's protocol ID: BIA-91067-109
Status last verified: Oct 2015
First submitted: 20 Jan 2012
Last updated: 3 Nov 2015
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02169466
Acronym / sponsor ID: BIA-91067-109
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD), Opicapone, BIA 9-1067
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 23 Jun 2014 (estimated)
Results: Posted 3 Nov 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Madopar® HBSPeriod 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Group 2	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Madopar® HBSPeriod 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Group 3	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Madopar® HBSPeriod 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Group 4	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Madopar® HBSPeriod 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

Who may qualify

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

Key inclusion criteria (8 listed)

Male subjects between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.
Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.

Key exclusion criteria (19 listed)

Subjects who did not conform to the above inclusion criteria, or
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.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.

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: OPC, OpicaponeOPC, Opicapone	Drug	Group 1, Group 2, Group 3, Group 4
PlaceboAlso: PLC, PlaceboPLC, Placebo	Drug	Group 1, Group 2, Group 3, Group 4
Madopar® HBScontrolled-release levodopa 100 mg/benserazide 25 mg	Drug	Group 1, Group 2, Group 3, Group 4

Primary outcome

Cmax - Maximum Observed Plasma Concentration of Levodopa
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
AUC0-t - Area Under the Plasma Concentration-time Curve
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
AUC0-∞ - AUC From Time Zero to Infinity
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
Tmax - Time to Cmax
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Primary pharmacokinetic parameter: tmax - time to Cmax

Results and safety

Results posted to the registry on 3 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: 25, 50, 100, Placebo	6	5
BIA 9-1067: 50, 100, Placebo, 25	6	5
BIA 9-1067: 100, Placebo, 25, 50	5	5
BIA 9-1067: Placebo, 25, 50, 100	5	5

Primary outcome: Cmax - Maximum Observed Plasma Concentration of Levodopa

Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.. Mean (Standard Deviation). Unit: ng/mL

Measure	BIA 9-1067 25 mg n = 20	BIA 9-1067 50 mg n = 20	BIA 9-1067 100 mg n = 20	Placebo n = 20
Value	314 (110)	266 (77.5)	263 (94.9)	260 (119)

Population analysed: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.

Primary outcome: AUC0-t - Area Under the Plasma Concentration-time Curve

Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.. Mean (Standard Deviation). Unit: ng.h/mL

Measure	BIA 9-1067 25 mg n = 20	BIA 9-1067 50 mg n = 20	BIA 9-1067 100 mg n = 20	Placebo n = 20
Value	1084 (398)	1064 (365)	1140 (592)	933 (422)

Population analysed: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.

Primary outcome: AUC0-∞ - AUC From Time Zero to Infinity

Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.. Mean (Standard Deviation). Unit: ng.h/mL

Measure	BIA 9-1067 25 mg n = 19	BIA 9-1067 50 mg n = 20	BIA 9-1067 100 mg n = 19	Placebo n = 19
Value	1190 (441)	1181 (373)	1326 (604)	1086 (380)

Population analysed: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.

Primary outcome: Tmax - Time to Cmax

Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.. Mean (Full Range). Unit: hours

Measure	BIA 9-1067 25 mg n = 20	BIA 9-1067 50 mg n = 20	BIA 9-1067 100 mg n = 20	Placebo n = 20
Value	2.50 (1.0 to 4.0)	2.50 (1.0 to 4.0)	2.00 (1.0 to 6.0)	2.00 (1.0 to 4.0)

Population analysed: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.

Adverse events

Time frame: Just before drug administration until 72 h post-dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIA 9-1067 25 mg	0 of 21 (0%)	2 of 21 (9.5%)	Not reported
BIA 9-1067 50 mg	0 of 22 (0%)	4 of 22 (18.2%)	Not reported
BIA 9-1067 100 mg	0 of 22 (0%)	3 of 22 (13.6%)	Not reported
Placebo	0 of 21 (0%)	2 of 21 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.

The record lists no contact. Use the official record to reach the sponsor.

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 and Madopar® HBS in people with Parkinson's Disease (PD), 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 8 inclusion and 19 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 3 Nov 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. 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 3 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 of Levodopa (time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.). The study lists 4 primary outcomes in all. 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 NCT02169466.

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 3 Nov 2015.