Parkinson DiseasePhase 1NCT03091543

Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics

A Phase 1 study testing Madopar® HBS 125, BIA 6-512 25 mg dose and BIA 6-512 50 mg dose in people with Parkinson Disease, 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 four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety of four single oral doses of BIA 6-512 (25… 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?: Madopar® HBS 125, BIA 6-512 25 mg dose and BIA 6-512 50 mg dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 sitePortugal
Study dates: 4 May 2004to 23 Jul 2004
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

Male or female subjects aged 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 (including neurological examination), and 12-lead ECG.
Subjects who had clinical laboratory tests within normal reference values.
Subjects who were negative for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab tests at screening.
Subjects who had negative for alcohol and drugs of abuse at screening and each admission to each treatment period.

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Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to each treatment period.

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 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 and/or first admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had used prescription or over-the-counter medication within 2 weeks of first admission.
Subjects who had used any investigational drug and/or participated in any clinical trial within 4 months of their first admission.
Subjects who had donated and/or received any blood or blood products within the previous 4 months prior to screening.
Subjects who were vegetarians, vegans and/or have medical dietary restrictions.
Subjects who cannot 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.
(If female) She was pregnant or breast-feeding.
(If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Human Pharmacology Unit (UFH)
S. Mamede Do Coronado, 4745-457

Other trials in Portugal

About this study

Official title: A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg

Read the detailed description

Single centre, double-blind, randomised, placebo-controlled, crossover study with five single-dose treatment periods, with a washout period between doses of 5 days or more. In each of the five consecutive treatment periods, eligible subjects were admitted to the UFH in the day prior to receiving the study medication. On the morning of the dosing day, subjects received BIA 6-512/Placebo concomitantly with Madopar® HBS 125 in fasting conditions (at least 8 hours) and remained in the UFH until at least 24 h post-dose; then, they were discharged and returned for the next period or the follow-up visit. Blood samples for the assay of plasma BIA 6-512, levodopa and 3-O-methyldopa (3-OMD) were taken at the following times: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.

Conditions: Parkinson Disease
Being tested: Madopar® HBS 125, Placebo, BIA 6-512 25 mg dose, BIA 6-512 50 mg dose, BIA 6-512 100 mg dose
Medical subject headings: Parkinson Disease

What participants receive

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

Madopar® HBS 125Drug
1 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.
PlaceboDrug
2 capsules of placebo
BIA 6-512 25 mg doseDrug
1 capsule of 25 mg plus 1 capsule of placebo
BIA 6-512 50 mg doseDrug
2 capsules of 25 mg
BIA 6-512 100 mg doseDrug
1 capsule of 100 mg plus 1 capsule of placebo
BIA 6-512 200 mg doseDrug
2 capsules of 100 mg

Study groups in NCT03091543
Study group	Role	What they receive
Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo)	Experimental	Concomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more. Receives: Drug: Madopar® HBS 125; Drug: Placebo; Drug: BIA 6-512 25 mg dose; Drug: BIA 6-512 50 mg dose; Drug: BIA 6-512 100 mg dose; Drug: BIA 6-512 200 mg dose
Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg)	Experimental	Concomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more. Receives: Drug: Madopar® HBS 125; Drug: Placebo; Drug: BIA 6-512 25 mg dose; Drug: BIA 6-512 50 mg dose; Drug: BIA 6-512 100 mg dose; Drug: BIA 6-512 200 mg dose
Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg)	Experimental	Concomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more. Receives: Drug: Madopar® HBS 125; Drug: Placebo; Drug: BIA 6-512 25 mg dose; Drug: BIA 6-512 50 mg dose; Drug: BIA 6-512 100 mg dose; Drug: BIA 6-512 200 mg dose
Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg)	Experimental	Concomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more. Receives: Drug: Madopar® HBS 125; Drug: Placebo; Drug: BIA 6-512 25 mg dose; Drug: BIA 6-512 50 mg dose; Drug: BIA 6-512 100 mg dose; Drug: BIA 6-512 200 mg dose
Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)	Experimental	Concomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more. Receives: Drug: Madopar® HBS 125; Drug: Placebo; Drug: BIA 6-512 25 mg dose; Drug: BIA 6-512 50 mg dose; Drug: BIA 6-512 100 mg dose; Drug: BIA 6-512 200 mg dose

What is being measured

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

Maximum observed plasma drug concentration (Cmax) post-dose - Levodopa
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Time of occurrence of Cmax (tmax) - Levodopa
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - Levodopa
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - Levodopa
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - Levodopa
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax) post-dose - BIA 6-512
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Time of occurrence of Cmax (tmax) - BIA 6-512
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - BIA 6-512
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - BIA 6-512
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - BIA 6-512
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.

Secondary outcomes (5)

Maximum observed plasma drug concentration (Cmax) post-dose - 3-OMD
Pharmacokinetic parameters of 3-O-methyldopa (3-OMD) following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Time of occurrence of Cmax (tmax) - 3-OMD
Pharmacokinetic parameters of 3-O-methyldopa (3-OMD) following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - 3-OMD
Pharmacokinetic parameters of 3-O-methyldopa (3-OMD) following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - 3-OMD
Pharmacokinetic parameters of 3-O-methyldopa (3-OMD) following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - 3-OMD
Pharmacokinetic parameters of 3-O-methyldopa (3-OMD) following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Measured: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.

Timeline

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

4 May 200423 Jul 2004

First posted27 Mar 2017
Study start4 May 2004
Primary completion23 Jul 2004
Study completion23 Jul 2004

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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03091543
Sponsor's protocol ID: BIA-6512-101
Status last verified: Mar 2017
First submitted: 21 Mar 2017
Last updated: 27 Mar 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg
ClinicalTrials.gov ID: NCT03091543
Acronym / sponsor ID: BIA-6512-101
Conditions: Parkinson Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: 4 May 2004 (actual)
Primary completion: 23 Jul 2004 (actual)
Study completion: 23 Jul 2004 (actual)
First posted: 27 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 5

Arm	Type	Receives
Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo)	Experimental	Drug: Madopar® HBS 125, Drug: Placebo, Drug: BIA 6-512 25 mg dose, Drug: BIA 6-512 50 mg dose, Drug: BIA 6-512 100 mg dose, Drug: BIA 6-512 200 mg doseConcomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more.
Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg)	Experimental	Drug: Madopar® HBS 125, Drug: Placebo, Drug: BIA 6-512 25 mg dose, Drug: BIA 6-512 50 mg dose, Drug: BIA 6-512 100 mg dose, Drug: BIA 6-512 200 mg doseConcomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more.
Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg)	Experimental	Drug: Madopar® HBS 125, Drug: Placebo, Drug: BIA 6-512 25 mg dose, Drug: BIA 6-512 50 mg dose, Drug: BIA 6-512 100 mg dose, Drug: BIA 6-512 200 mg doseConcomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more.
Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg)	Experimental	Drug: Madopar® HBS 125, Drug: Placebo, Drug: BIA 6-512 25 mg dose, Drug: BIA 6-512 50 mg dose, Drug: BIA 6-512 100 mg dose, Drug: BIA 6-512 200 mg doseConcomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more.
Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)	Experimental	Drug: Madopar® HBS 125, Drug: Placebo, Drug: BIA 6-512 25 mg dose, Drug: BIA 6-512 50 mg dose, Drug: BIA 6-512 100 mg dose, Drug: BIA 6-512 200 mg doseConcomitantly with the BIA 6-512/Placebo dose, subjects will be administered levodopa/benserazide 100/25 mg. All subjects attended to each 5 treatment periods and received a different dose of BIA 6-512 or placebo in combination with a single-dose of controlled release levodopa/benserazide 100/25 mg in each of these treatment periods. The washout period between periods was 5 days or more.

Who may qualify

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

Key inclusion criteria (10 listed)

Male or female subjects aged 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 (including neurological examination), and 12-lead ECG.
Subjects who had clinical laboratory tests within normal reference values.
Subjects who were negative for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab tests 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
Madopar® HBS 1251 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)
Placebo2 capsules of placebo	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)
BIA 6-512 25 mg dose1 capsule of 25 mg plus 1 capsule of placebo	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)
BIA 6-512 50 mg dose2 capsules of 25 mg	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)
BIA 6-512 100 mg dose1 capsule of 100 mg plus 1 capsule of placebo	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)
BIA 6-512 200 mg dose2 capsules of 100 mg	Drug	Sequence A (25 mg - 50 mg - 100 mg - 200 mg - Placebo), Sequence B (Placebo - 25 mg - 50 mg - 100 mg - 200 mg), Sequence C (200 mg - Placebo - 25 mg - 50 mg - 100 mg), Sequence D (100 mg - 200 mg - Placebo - 25 mg - 50 mg), Sequence E (50 mg - 100 mg - 200 mg - Placebo - 25 mg)

Primary outcome

Maximum observed plasma drug concentration (Cmax) post-dose - Levodopa
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Time of occurrence of Cmax (tmax) - Levodopa
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - Levodopa
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - Levodopa
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - Levodopa
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of Levodopa following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Maximum observed plasma drug concentration (Cmax) post-dose - BIA 6-512
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Time of occurrence of Cmax (tmax) - BIA 6-512
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - BIA 6-512
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - BIA 6-512
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - BIA 6-512
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Pharmacokinetic parameters of BIA 6-512 following oral administration of single-doses of Madopar® HBS 125 concomitantly with placebo or BIA 6-512 25 mg, 50 mg, 100 mg and 200 mg

5 secondary outcomes

Maximum observed plasma drug concentration (Cmax) post-dose - 3-OMD
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Time of occurrence of Cmax (tmax) - 3-OMD
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule - 3-OMD
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞), calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant - 3-OMD
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.
Apparent terminal half-life, calculated from ln 2/λz (t1/2) - 3-OMD
Time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours 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 27 Mar 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.

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 Madopar® HBS 125, BIA 6-512 25 mg dose and BIA 6-512 50 mg dose in people with Parkinson Disease, 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 10 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 27 Mar 2017. 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?

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 plasma drug concentration (Cmax) post-dose - Levodopa (time frame: pre-dose, ¼, ½, 1, 1½, 2, 3, 4, 6, 9, 12, 16 and 24 hours post-dose.). The study lists 10 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 NCT03091543.

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 27 Mar 2017.