BIAL
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About
The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.
Full description
The study was conducted in two parts, with separate groups of subjects participating in each part.
Part 1 was designed as follows:
The proposed doses to be used in Part 1 of the study were 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg.
In Part 2 of the study, an additional group of eight subjects was to receive a single dose of BIA 3-202, either having fasted overnight or with a high fat meal, in an open label two-way crossover design. Each treatment was to be separated by a period of at least 7 days.
The dose administered in Part 2 was to be determined from the safety and pharmacokinetic data from Part 1 of the study.
Following the review of Part 1 data, protocol amendment 1 was issued, in which it was stated that the dose of BIA 3-202 to be used was 400 mg.
Screening Potential subjects were screened for eligibility within 28 days of admission. Screening consisted of review of medical history, physical examination, neurological examination, vital signs, 12 lead ECG, clinical laboratory safety tests (haematology, coagulation plasma biochemistry, urinalysis, urinary microproteins, HbsAg, anti-HCV and HIV I & II, drugs of abuse and alcohol screen).
Treatment Periods The results of screening were known to the Investigator prior to the subject's admission. On admission the inclusion/exclusion criteria were reviewed and subject written informed consent was obtained.
Eligible subjects were to be admitted to the unit for one treatment period (groups 1-7, in Part 1 of the study) or two treatment periods (group 8, Part 2), on the day prior to receiving trial medication and were to remain in the unit under clinical supervision until at least 24 hours post dose.
BIA 3-202 /placebo was to be administered orally in the morning of day 1.
Safety was to be evaluated by monitoring of adverse events, clinical laboratory safety tests (haematology, biochemistry, coagulation, urinalysis, and urinary microproteins), vital signs, 12-lead ECG, and physical examination, including brief neurological examinations.
Blood samples and urine collections were to be taken at pre-determined time-points for the assay of BIA 3-202 and its metabolite BIA 3-270. Blood samples were also to be taken for the assessment of COMT activity in erythrocytes.
Follow Up Subjects were to attend for a follow up visit 5-7 days following their last discharge. At follow-up, medical history and adverse events were to be reviewed, and clinical laboratory safety tests were to be performed.
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71 participants in 9 patient groups
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Data sourced from clinicaltrials.gov
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