Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Nebicapone
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- 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 Ab and HIV-1 and HIV-2 Ab tests at screening.
- Subjects who were negative for drugs of abuse and alcohol at screening and admission.
- Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
- (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
Exclusion Criteria:
- Subjects who did not conform to the above inclusion criteria, or
- 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 or drug abuse.
- Subjects who consumed more than 21 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 oral contraceptives or over the counter medication excluding oral 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 the previous 2 months prior to screening.
- Subjects who were vegetarians, vegans and/or have 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.
- (If female) She was pregnant or breast-feeding.
- (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
- Subjects who were unwilling or unable to give written informed consent.
Sites / Locations
- Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Nebicapone 100 mg / Placebo
Nebicapone 200 mg / Placebo
Nebicapone 300 mg / Placebo
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.