Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

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: NCT02287415
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Multiple-dose, open-label, single-period study consisting of three consecutive phases

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

Detailed Description:
Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Study Start Date : May 2002
Actual Primary Completion Date : July 2002
Actual Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Group 1
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Drug: Warfarin
Other Name: Uniwarfin




Primary Outcome Measures :
  1. Cmax - Maximum Steady-state Plasma Concentration [ Time Frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose. ]

Secondary Outcome Measures :
  1. Tmax - Time of Occurrence of Cmax [ Time Frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose. ]
  2. AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval [ Time Frame: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose. ]


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.


Layout table for eligibility information
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 28 kg/m2, inclusive
  • 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 clinically acceptable
  • Subjects who were negative for HBs Ag, anti-HCV Ab and anti-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
  • In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device
  • In case of female volunteers, subjects who 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, endocrine, connective tissue diseases or disorders
  • Subjects who had a current haemostatic disorder or a personal or family history of any such disorder
  • Subjects who had a personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
  • Subjects with a profession or activities implying a special risk of trauma
  • Subjects with any abnormality in the coagulation status (aPTT or prothrombin INR)
  • 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 prescription drugs within 2 weeks prior admission on Phase A
  • Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months prior admission to Phase A
  • 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 admission to Phase A
  • Subjects who were vegetarians, vegans and/or had medical dietary restrictions
  • Subjects who could not communicate reliably with the investigator

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02287415    
Other Study ID Numbers: BIA-2093-108
First Posted: November 10, 2014    Key Record Dates
Results First Posted: December 1, 2014
Last Update Posted: December 1, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Warfarin
Anticoagulants
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action