- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02287415
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
November 28, 2014 updated by: Bial - Portela C S.A.
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Multiple-dose, open-label, single-period study consisting of three consecutive phases
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
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.
|
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
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Primary Completion (Actual)
July 1, 2002
Study Completion (Actual)
July 1, 2002
Study Registration Dates
First Submitted
November 6, 2014
First Submitted That Met QC Criteria
November 7, 2014
First Posted (Estimate)
November 10, 2014
Study Record Updates
Last Update Posted (Estimate)
December 1, 2014
Last Update Submitted That Met QC Criteria
November 28, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIA-2093-108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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