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COMPLETEDPHASE1

Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers

NCT02763800•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

The objectives as stated in the study protocol were as follows: * To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A * To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A * To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B * To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B

Detailed Description

This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (Part A) and a single group of healthy elderly volunteers (Part B). In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly allocated to BIA 3-202 and two to placebo.

Eligibility

Age

18 - 35 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
•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 and HIV I and II tests at screening.
•Subjects who were negative for drugs of abuse and alcohol tests 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.
•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.
+17 more criteria

Locations (1)

Guy's Drug Research Unit

London, United Kingdom

Key Dates

Start Date

September 1, 2000

Primary Completion Date

January 1, 2001

Completion Date

January 1, 2001

Last Updated

May 5, 2016

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

BIA 3-202

DRUG

Placebo

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

Inclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations