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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763800
• Other study ID #: BIA-3202-02
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2016
• Last updated: May 4, 2016
• Start date: September 2000
• Est. completion date: January 2001

Study information

• Verified date: May 2016
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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.
• Placebo
Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Locations

Country	Name	City	State
United Kingdom	Guy's Drug Research Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) - D1		Day 1	No
Primary	Time of maximum observed concentration (tmax) - D1		Day 1	No
Primary	Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1		Day 1	No
Primary	Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D1		Day 1	No
Primary	Maximum observed plasma concentration (Cmax) - D9		Day 9	No
Primary	Time of maximum observed concentration (tmax) - D9		Day 9	No
Primary	Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9		Day 9	No
Primary	Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) - D9		Day 9	No