A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Epilepsy
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Total Number of Adverse Events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers
Detailed Description
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m
- •Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
- •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 previous smokers who had not smoked for at least 6 months.
- •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 (carbamazepine and
- •related compounds).
- •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.
Arms & Interventions
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: Placebo
Group 1- 200 mg b.i.d. (twice daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: Placebo
Group 1- 200 mg b.i.d. (twice daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: BIA 2-093
Group 2 - 400 mg b.i.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: Placebo
Group 2 - 400 mg b.i.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: BIA 2-093
Group 3- 800 mg o.d. (once daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: Placebo
Group 3- 800 mg o.d. (once daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: BIA 2-093
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention: BIA 2-093
Outcomes
Primary Outcomes
Total Number of Adverse Events
Time Frame: up to 20 weeks
Total Number of Adverse Events.
Secondary Outcomes
- Cmax(Day 1 and Day 8)
- AUC0-τ(Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose)