A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers

NCT01879345 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Keywords

Anticonvulsant

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events Reported

  investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient

  3 weeks

Secondary Outcomes (3)

• Cmax - Maximum Observed Plasma Drug Concentration

  Day 1 and Day 7

• Tmax - the Time of Occurrence of Cmax

  Day 1 and Day 7

• AUC0-τ

  Day 1 and Day 7

Study Arms (3)

BIA 2-093 - 1800 mg (Group 1)

EXPERIMENTAL

3 tablets of BIA 2-093 600 mg

Drug: BIA 2-093 - 1800 mg (Group 1)

BIA 2-093 - 2400 mg (Group 2)

EXPERIMENTAL

4 tablets of BIA 2-093 600 mg

Drug: BIA 2-093 - 2400 mg (Group 2)

Placebo

PLACEBO COMPARATOR

placebo tablets

Drug: Placebo

Interventions

BIA 2-093 - 1800 mg (Group 1) DRUG

3 tablets of BIA 2-093

Also known as: Eslicarbazepine acetate

BIA 2-093 - 1800 mg (Group 1)

BIA 2-093 - 2400 mg (Group 2) DRUG

4 tablets of BIA 2-093 600 mg

Also known as: Eslicarbazepine acetate

BIA 2-093 - 2400 mg (Group 2)

Placebo DRUG

placebo tablets

Also known as: sugar pills

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Human Pharmacology Unit - BIAL - Portela & Ca, S.A.

Trofa, Coronado (S.Romão E S. Mamede), 4745-457, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Manuel Vaz da Silva, MD, PhD

  Human Pharmacology Unit / BIAL - Portela & Ca, S.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 17, 2013
• Study Start: October 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: April 8, 2025
• Results First Posted: December 30, 2014

Record last verified: 2025-03

Locations

PT (1)