A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093

NCT02171195 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.

Conditions

Epilepsy

Keywords

Eslicarbazepine acetate; BIA 2-093; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Total Number of Adverse Events

  An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product

  up to 20 weeks

Study Arms (8)

Group 1 (20 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 2 (50 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 3 (100 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 4 (200 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 5 (400 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 6 (600 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 7 (900 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Group 8 (1200 mg)

EXPERIMENTAL

Drug: BIA 2-093; Drug: Placebo

Interventions

BIA 2-093 DRUG

BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg

Also known as: ESL, Eslicarbazepine acetate

Group 1 (20 mg); Group 2 (50 mg); Group 3 (100 mg); Group 4 (200 mg); Group 5 (400 mg); Group 6 (600 mg); Group 7 (900 mg); Group 8 (1200 mg)

Placebo DRUG

Identical placebo administered as oral tablets with 200 ml potable water.

Also known as: PLC

Group 1 (20 mg); Group 2 (50 mg); Group 3 (100 mg); Group 4 (200 mg); Group 5 (400 mg); Group 6 (600 mg); Group 7 (900 mg); Group 8 (1200 mg)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males aged 18-35 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 who 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, 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 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.
• Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.

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 22 9866100

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: July 1, 2000
• Primary Completion: October 1, 2000
• Study Completion: October 1, 2000
• Last Updated: July 20, 2016
• Results First Posted: January 7, 2015

Record last verified: 2016-07

Locations

GB (1)