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

NCT02287415 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-108
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Steady-state Plasma Concentration

  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 Outcomes (2)

• Tmax - Time of Occurrence of Cmax

  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.

• AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval

  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.

Study Arms (1)

Group 1

EXPERIMENTAL

Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

Drug: BIA 2-093; Drug: Warfarin

Interventions

BIA 2-093 DRUG

Also known as: ESL, Eslicarbazepine acetate

Group 1

Warfarin DRUG

Also known as: Uniwarfin

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Warfarin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: May 1, 2002
• Primary Completion: July 1, 2002
• Study Completion: July 1, 2002
• Last Updated: December 1, 2014
• Results First Posted: December 1, 2014

Record last verified: 2014-11