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

NCT02763852 | Completed Phase 1

• 1 other identifier: BIA-3202-104
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Nebicapone

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  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-∞)

  pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose

• Apparent terminal elimination half-life (t1/2)

  pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose

Study Arms (5)

BIA 3-202 50 mg

EXPERIMENTAL

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

BIA 3-202 100 mg

EXPERIMENTAL

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

BIA 3-202 200 mg

EXPERIMENTAL

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

BIA 3-202 300 mg

EXPERIMENTAL

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

BIA 3-202 400 mg

EXPERIMENTAL

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

BIA 3-202 DRUG

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.

BIA 3-202 100 mg; BIA 3-202 200 mg; BIA 3-202 300 mg; BIA 3-202 400 mg; BIA 3-202 50 mg

Placebo DRUG

Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route.

BIA 3-202 100 mg; BIA 3-202 200 mg; BIA 3-202 300 mg; BIA 3-202 400 mg

Madopar® 125 DRUG

Levodopa 100 mg/benserazide 25 mg capsules (Madopar® 125, marketed by Roche products Limited); oral route.

BIA 3-202 100 mg; BIA 3-202 200 mg; BIA 3-202 300 mg; BIA 3-202 400 mg; BIA 3-202 50 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Human Pharmacology Unit - BIAL - Portela & Ca, S.A.

S. Mamede Do Coronado, S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nebicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 5, 2016
• Study Start: April 1, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)