Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
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 for at least 6 months preceding screening.
- 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 (GDRU)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo
10 mg
30 mg
50 mg
100 mg
200 mg
400 mg
800 mg
Food Effect (fed/fasted)
Matched placebo was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
1 x 10 mg BIA 3-202 tablet BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
3 x 10 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
5 x 10 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
1 x 100 mg BIA 3-202 tablet BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
2 x 100 mg BIA 3-202 tablets
4 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
8 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)
400 mg BIA 3-202: 4 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)