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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287415
• Other study ID #: BIA-2093-108
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2014
• Last updated: November 28, 2014
• Start date: May 2002
• Est. completion date: July 2002

Study information

• Verified date: November 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093

• Warfarin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	AUCt - 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.	No