Trial Outcomes & Findings for The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin (NCT NCT02287415)

NCT ID: NCT02287415

Last Updated: 2014-12-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 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.
• Results posted on: 2014-12-01

Participant Flow

Participant milestones

Measure	Group 1 Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1 n=13 Participants Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Group 1 n=13 Participants Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
Cmax - Maximum Steady-state Plasma Concentration	31652 ng/mL Standard Deviation 11150

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group 1 n=13 Participants Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
Tmax - Time of Occurrence of Cmax	6 hours Interval 1.0 to 12.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group 1 n=13 Participants Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval	411834 ng.h/mL Standard Deviation 113305

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=13 participants at risk Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin BIA 2-093 Warfarin
Blood and lymphatic system disorders Lymphadenopathy inguinal	7.7% 1/13
Gastrointestinal disorders Epigastric discomfort	7.7% 1/13
General disorders Asthenia	7.7% 1/13
Musculoskeletal and connective tissue disorders Lumbago	7.7% 1/13
Musculoskeletal and connective tissue disorders Pain in elbow	7.7% 1/13
Nervous system disorders Dizziness	7.7% 1/13
Nervous system disorders Tension headache	7.7% 1/13
Nervous system disorders Syncope	7.7% 1/13
Nervous system disorders Vasovagal reaction	7.7% 1/13
Nervous system disorders Lipothymia	7.7% 1/13
Psychiatric disorders Irritability	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 1/13
Skin and subcutaneous tissue disorders Adhesive tape allergy	7.7% 1/13
Vascular disorders Hot flashes	7.7% 1/13

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Email: jose.rocha@bial.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place