Back to resultsStudy to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BIA 3-202
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Nebicapone
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.
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.
Sites / Locations
- Guy's Drug Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: BIA 3-202 50 mg/placebo
Group 2: BIA 3-202 100 mg/placebo
Group 3: BIA 3-202 200 mg/placebo
Group 4: BIA 3-202 200 mg/placebo
Arm Description
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 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 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 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
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) - D1
Time of maximum observed concentration (tmax) - D1
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
Maximum observed plasma concentration (Cmax) - D9
Time of maximum observed concentration (tmax) - D9
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02763800
Brief Title
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Nebicapone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: BIA 3-202 50 mg/placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2: BIA 3-202 100 mg/placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3: BIA 3-202 200 mg/placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4: BIA 3-202 200 mg/placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BIA 3-202
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Matched placebo was administered in the form of oral tablets, given with 200 ml potable water
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) - D1
Time Frame
Day 1
Title
Time of maximum observed concentration (tmax) - D1
Time Frame
Day 1
Title
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
Time Frame
Day 1
Title
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
Time Frame
Day 1
Title
Maximum observed plasma concentration (Cmax) - D9
Time Frame
Day 9
Title
Time of maximum observed concentration (tmax) - D9
Time Frame
Day 9
Title
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
Time Frame
Day 9
Title
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
Time Frame
Day 9
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Facility Information:
Facility Name
Guy's Drug Research Unit
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
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