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

BIAL

Status and phase

Completed

Phase 1

Conditions

Epilepsy

Treatments

Drug: BIA 2-093

Drug: Warfarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02287415

BIA-2093-108

Details and patient eligibility

About

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

Full 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

Enrollment

13 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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