Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Nebicapone
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.
Interventions
DRUGBIA 3-202
BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.
DRUGPlacebo
Matched placebo was administered in the form of oral tablets, given with 200 ml potable water
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9 | Day 9 |
| Maximum observed plasma concentration (Cmax) - D1 | Day 1 |
| Time of maximum observed concentration (tmax) - D1 | Day 1 |
| Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1 | Day 1 |
| Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1 | Day 1 |
| Maximum observed plasma concentration (Cmax) - D9 | Day 9 |
| Time of maximum observed concentration (tmax) - D9 | Day 9 |
| Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9 | Day 9 |
Countries
United Kingdom
Outcome results
None listed