Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject
1 other identifier
interventional
14
1 country
1
Brief Summary
This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedResults Posted
Study results publicly available
December 19, 2014
CompletedDecember 19, 2014
December 1, 2014
1 month
May 11, 2009
December 4, 2014
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
Study Arms (2)
Eslicarbazepine acetate
ACTIVE COMPARATOREslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Oxcarbazepine
ACTIVE COMPARATOROxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Interventions
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)
Eligibility Criteria
You may qualify if:
- Healthy subjects
- Aged 18-55 years
- Body mass index (18.5-29 kg/m3)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SGS LSS Clinical Pharmacology Unit Antwerpen
Antwerp, B-2060, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Research
- Organization
- Bial - Portela & Cª, S.A.
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Cavens, MD
SGS LSS Clinical Pharmacology Unit Antwerpen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 12, 2009
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
February 1, 2009
Last Updated
December 19, 2014
Results First Posted
December 19, 2014
Record last verified: 2014-12