CompletedNCT02763852Updated May 5, 2016

Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)

A Phase 1 interventional study of BIA 3-202 and Placebo in Parkinson's Disease, sponsored by Bial - Portela C S.A.. Completed at 1 site in Portugal. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-05.

Sponsored by Bial - Portela C S.A. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA 3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4 different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy volunteers.

Read the detailed description

This was a single centre, double-blind, randomised, placebo-controlled, single-graded-dose, crossover study with five single-dose treatment periods. The washout period between doses was 15±2 days. For each of the five treatment periods, volunteers were to be admitted at the UFH on the day before the treatment day. On each treatment period, the pre-dose assessment were to be completed, BIA 3-202/Placebo was to be administered concomitantly with the dose of Madopar® 125 and post-dose assessments were to be completed. Subjects were discharged 30 h post-dose. Subjects should attend five treatment periods and were to receive a different dose of BIA 3-202 or placebo during each of these treatment periods.

Conditions studied

Parkinson's Disease

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Parkinson Disease 4,488

Keywords

Parkinson's Disease
Nebicapone

In context

Parkinson Disease

4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.

This study's enrollment of 18 is below the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.

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Lead sponsor

Bial - Portela C S.A. is the lead sponsor of 133 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male and female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
Subjects who were healthy as determined by pre study medical history, physical examination, and 12- lead ECG.
Subjects who had clinical laboratory tests acceptable to the investigator.
Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for drugs of abuse at screening and admission.
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 a woman) 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.

Exclusion criteria

Exclusion Criteria:

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, 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.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 28 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening and/or admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had an acute infection such as influenza at the time of screening and/or admission.
Subjects who had used prescription drugs within 4 weeks of first dosing.
Subjects who had used oral contraceptives or over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to the study.
Subjects who had previously received BIA 3-202.
Subjects who had donated and/or received any blood or blood products within the previous 3 months prior to screening.
Subjects who were vegetarians, vegans and/or had 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.
(If woman) She was pregnant or breast-feeding.
(If woman) She was at childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
Subjects who were unwilling or unable to give written informed consent.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 18 participants (actual)

Study arms

Experimental
BIA 3-202 50 mg
BIA 3-202 single-dose plus 1 tablet of Madopar 125. BIA 3-202 50 mg: 5 tablets of 10 mg. The investigational products were administered orally, following an overnight fast of at least 7 hours, with approximately 200 mL of potable water.
Drug: BIA 3-202 · Drug: Madopar® 125
Experimental
BIA 3-202 100 mg
BIA 3-202/Placebo single-dose plus 1 tablet of Madopar 125. BIA 3-202 100 mg: 1 tablet of 100 mg + 4 placebo tablets. The investigational products were administered orally, following an overnight fast of at least 7 hours, with approximately 200 mL of potable water.
Drug: BIA 3-202 · Drug: Placebo · Drug: Madopar® 125
Experimental
BIA 3-202 200 mg
BIA 3-202/Placebo single-dose plus 1 tablet of Madopar 125. BIA 3-202 200 mg: 2 tablet of 100 mg + 3 placebo tablets. The investigational products were administered orally, following an overnight fast of at least 7 hours, with approximately 200 mL of potable water
Drug: BIA 3-202 · Drug: Placebo · Drug: Madopar® 125
Experimental
BIA 3-202 300 mg
BIA 3-202/Placebo single-dose plus 1 tablet of Madopar 125. BIA 3-202 300 mg: 3 tablet of 100 mg + 2 placebo tablets. The investigational products were administered orally, following an overnight fast of at least 7 hours, with approximately 200 mL of potable water.
Drug: BIA 3-202 · Drug: Placebo · Drug: Madopar® 125
Experimental
BIA 3-202 400 mg
BIA 3-202/Placebo single-dose plus 1 tablet of Madopar 125. BIA 3-202 400 mg: 4 tablet of 100 mg + 1 placebo tablets. The investigational products were administered orally, following an overnight fast of at least 7 hours, with approximately 200 mL of potable water
Drug: BIA 3-202 · Drug: Placebo · Drug: Madopar® 125

Interventions

DrugBIA 3-202
The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose. Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods.
DrugPlacebo
Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route.
DrugMadopar® 125
Levodopa 100 mg/benserazide 25 mg capsules (Madopar® 125, marketed by Roche products Limited); oral route.

What researchers measure

Primary outcomes

Maximum observed plasma concentration (Cmax)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose
Apparent terminal elimination half-life (t1/2)
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose

Study locations

1 site

Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
S. Mamede do Coronado, 4745-457, Portugal

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02763852
Lead sponsor: Bial - Portela C S.A.
Responsible party: Sponsor
First posted: May 5, 2016
Start date: Apr 2001
Primary completion: Jul 2001
Completion: Jul 2001
Last update: May 5, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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