Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

• Status: Completed
• Trial end date: 2001-01-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.

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.