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

NCT ID: NCT02763800

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2001-01-31

Brief 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: BIA 3-202 50 mg/placebo

Group 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9.

50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets

Group Type: EXPERIMENTAL

BIA 3-202

Intervention Type: DRUG

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Placebo

Intervention Type: DRUG

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Group 2: BIA 3-202 100 mg/placebo

Group 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9.

100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet

Group Type: EXPERIMENTAL

BIA 3-202

Intervention Type: DRUG

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Placebo

Intervention Type: DRUG

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Group 3: BIA 3-202 200 mg/placebo

Group 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.

200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets

Group Type: EXPERIMENTAL

BIA 3-202

Intervention Type: DRUG

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Placebo

Intervention Type: DRUG

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Group 4: BIA 3-202 200 mg/placebo

Group 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.

200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets

Group Type: EXPERIMENTAL

BIA 3-202

Intervention Type: DRUG

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Placebo

Intervention Type: DRUG

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Interventions

BIA 3-202

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Intervention Type: DRUG

Placebo

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Intervention Type: DRUG

Eligibility Criteria

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.
• Subjects who had a history of relevant atopy.
• Subjects who had a history of relevant drug hypersensitivity.
• Subjects who had a history of alcoholism.
• Subjects who had a history of 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 over the counter medication, excluding 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 this study.
• Subjects who had previously received BIA 3-202.
• Subjects who had donated and/or received any blood or blood products within 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.
• Subjects who were unwilling or unable to give written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guy's Drug Research Unit

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

BIA-3202-02

Identifier Type: -

Identifier Source: org_study_id