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

NCT02171234 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Keywords

Epilepsy; BIA 2-093; Eslicarbazepine acetate

Outcome Measures

Primary Outcomes (1)

• Total Number of Adverse Events

  Total Number of Adverse Events.

  up to 20 weeks

Secondary Outcomes (2)

• 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

Study Arms (4)

Group 1- 200 mg b.i.d. (twice daily)

EXPERIMENTAL

BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.

Drug: Placebo; Drug: BIA 2-093

Group 2 - 400 mg b.i.d.

EXPERIMENTAL

BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.

Drug: Placebo; Drug: BIA 2-093

Group 3- 800 mg o.d. (once daily)

EXPERIMENTAL

BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.

Drug: Placebo; Drug: BIA 2-093

Group 4 - either 800 mg b.i.d or 1200 mg o.d.

EXPERIMENTAL

BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.

Drug: Placebo; Drug: BIA 2-093

Interventions

Placebo DRUG

Also known as: PLC, Placebo

Group 1- 200 mg b.i.d. (twice daily); Group 2 - 400 mg b.i.d.; Group 3- 800 mg o.d. (once daily); Group 4 - either 800 mg b.i.d or 1200 mg o.d.

BIA 2-093 DRUG

Also known as: ESL, Eslicarbazepine acetate

Group 1- 200 mg b.i.d. (twice daily); Group 2 - 400 mg b.i.d.; Group 3- 800 mg o.d. (once daily); Group 4 - either 800 mg b.i.d or 1200 mg o.d.

Eligibility Criteria

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

You may qualify if:

• Adult males aged 18-45 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, 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.

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, 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.
• 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 dosing.
• Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Guy's Drug Research Unit

London, SE1 1YR, United Kingdom

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.

francisco.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: February 1, 2001
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: January 7, 2015
• Results First Posted: January 7, 2015

Record last verified: 2014-12

Locations

GB (1)