Clinical trial NCT01879345: A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Official title: A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: Anticonvulsant
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.

Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

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.

Primary outcomes:
measure: Number of Adverse Events Reported
timeFrame: 3 weeks
Secondary outcomes:
measure: Cmax - Maximum Observed Plasma Drug Concentration
timeFrame: Day 1 and Day 7
measure: Tmax - the Time of Occurrence of Cmax
timeFrame: Day 1 and Day 7
measure: AUC0-τ
timeFrame: Day 1 and Day 7
Other outcomes:
Locations:
city: Trofa
country: Portugal
facility: Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
state: Coronado (S.Romão E S. Mamede)
Study officials:
affiliation: Human Pharmacology Unit / BIAL - Portela & Ca, S.A.
name: Manuel Vaz da Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: