Phase 1
N=18
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01879345 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Number of Adverse Events Reported — 10; 7; 7 Number of adverse events reported
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BIA 2-093 - 1800 mg (Group 1) (Drug); BIA 2-093 - 2400 mg (Group 2) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events Reported |
10; 7; 7 | — |
| SECONDARY Cmax - Maximum Observed Plasma Drug Concentration |
34569; 35926; 47665; 56506; 241; 508 | — |
| SECONDARY Tmax - the Time of Occurrence of Cmax |
3.8; 3.3; 2.1; 3.6; 4.67; 4.00 | — |
| SECONDARY AUC0-τ |
507563; 445596; 740299; 905860; 3589; 4547 | — |
Summary
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers
Eligibility Criteria
Inclusion Criteria
- Male subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests within normal ranges at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
- Subjects who were negative for drugs of abuse and alcohol at screening and admission.
- Subjects who were non-smokers or 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, OR
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, 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 14 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used prescription or over-the-counter medication within 2 weeks of admission.
- Subjects who had used any investigational drug or participated in any clinical trial within 3 months of admission.
- Subjects who had previously received BIA 2-093.
- Subjects who had donated or received any blood or blood products within the previous 3 months prior to screening.
- Subjects who were vegetarians, vegans 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.
Data sourced from ClinicalTrials.gov (NCT01879345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.