Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites

This study has been terminated.
(occurrence of a serious adverse event)
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT02172755
First received: June 23, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

The purpose of this study is to determine the effects of age on the pharmacokinetic profile of BIA 2-093 and its active metabolites.


Condition Intervention Phase
Epilepsy
Drug: BIA 2-093
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites in Healthy Elderly Subjects Compared With Those in Healthy Young Subjects

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • maximum drug concentration (Cmax) [ Time Frame: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose ] [ Designated as safety issue: No ]
  • maximum drug concentration (Cmax) [ Time Frame: From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose. ] [ Designated as safety issue: No ]
  • time at which the Cmax occurred (tmax) [ Time Frame: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose. ] [ Designated as safety issue: No ]
  • time at which the Cmax occurred (tmax) [ Time Frame: From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIA 2-093 600 mg, single dose
The 600 mg dose of BIA 2-093 consisted of 1 tablet strength 600 mg (batch 20168); oral route
Drug: BIA 2-093
During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Other Name: Eslicarbazepine acetate
Experimental: BIA 2-093 600 mg, multiple dose
The 600 mg dose of BIA 2-093 consisted of 1 tablet strength 600 mg (batch 20168); oral route.
Drug: BIA 2-093
During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Other Name: Eslicarbazepine acetate

Detailed Description:

This was a single-centre, open-label, parallel group, non-randomised study with a single-dose phase (Phase A) followed by a multiple-dose phase (Phase B), in 12 healthy elderly and 12 healthy young subjects. During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.
  • If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
  • Subjects who had clinical laboratory tests acceptable to the Investigator.
  • Subjects who were negative for HBsAg, HCVAb and HIV-1 and HIV-2 Ab tests at screening.
  • Subjects who were negative for alcohol and drugs of abuse at screening.
  • 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.
  • (If female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.
  • (If female and with less than 40 years old) She had a negative pregnancy test at screening.

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.
  • 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 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 used drugs within 2 weeks of first dosing.
  • Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
  • Subjects who had previously received BIA 2-093.
  • Subjects who had donated and/or received any blood or blood products within the previous 2 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.
  • (If female) She was pregnant or breast-feeding
  • (If female) She was of childbearing potential and she did not use an authorised effective contraceptive method.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02172755

Locations
Germany
Scope International Life Sciences AG,
Hamburg, Germany, D-22525
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02172755     History of Changes
Other Study ID Numbers: BIA-2093-105
Study First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine acetate
BIA 2-093

Additional relevant MeSH terms:
Eslicarbazepine acetate
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014