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Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

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ClinicalTrials.gov Identifier: NCT02281591
Recruitment Status : Completed
First Posted : November 3, 2014
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: S-licarbazepine Drug: R-licarbazepine Phase 1

Detailed Description:
Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine Following Oral Administration in Healthy Volunteers
Study Start Date : June 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eslicarbazepine acetate
900mg of eslicarbazepine acetate (ESL, BIA 2-093)
Drug: BIA 2-093
Tablets containing 900 mg

Active Comparator: S-licarbazepine R-licarbazepine
450 mg of S-licarbazepine plus 450 mg of R-licarbazepine
Drug: S-licarbazepine
capsules containing 225 mg

Drug: R-licarbazepine
capsules containing 225 mg

Active Comparator: S-licarbazepine
450 mg of S-licarbazepine
Drug: S-licarbazepine
capsules containing 225 mg

Active Comparator: R-licarbazepine
450 mg of Rlicarbazepine
Drug: R-licarbazepine
capsules containing 225 mg




Primary Outcome Measures :
  1. Cmax - the Maximum Plasma Concentration [ Time Frame: Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. ]
  2. Tmax - the Time of Occurrence of Cmax [ Time Frame: Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. ]
  3. AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [ Time Frame: Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. ]

Secondary Outcome Measures :
  1. AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point [ Time Frame: Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Male or female 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 clinically acceptable 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 who smoke < 10 cigarettes or equivalent per day.
  • Subjects who are able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
  • (If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, OR
  • 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 (especially carbamazepine or oxcarbazepine).
  • 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.

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): NCT02281591


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

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02281591     History of Changes
Other Study ID Numbers: BIA-2093-115
First Posted: November 3, 2014    Key Record Dates
Results First Posted: December 3, 2014
Last Update Posted: December 3, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Eslicarbazepine acetate
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action