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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171195
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : January 7, 2015
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: Placebo Phase 1

Detailed Description:
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 When Given to Healthy Male Adult Volunteers.
Study Start Date : July 2000
Actual Primary Completion Date : October 2000
Actual Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Group 1 (20 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 2 (50 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 3 (100 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 4 (200 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 5 (400 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 6 (600 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 7 (900 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC

Experimental: Group 8 (1200 mg) Drug: BIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Other Name: ESL, Eslicarbazepine acetate

Drug: Placebo
Identical placebo administered as oral tablets with 200 ml potable water.
Other Name: PLC




Primary Outcome Measures :
  1. Total Number of Adverse Events [ Time Frame: up to 20 weeks ]
    An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria.
  • 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.
  • Subjects who were vegetarians, vegans and/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.
  • Subjects who were unwilling or unable to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171195


Locations
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United Kingdom
Guy's Drug Research Unit
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02171195    
Other Study ID Numbers: BIA-2093-101
First Posted: June 24, 2014    Key Record Dates
Results First Posted: January 7, 2015
Last Update Posted: July 20, 2016
Last Verified: July 2016
Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine acetate
BIA 2-093
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action