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Trial Outcomes & Findings for Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin (NCT NCT02169440)

NCT ID: NCT02169440

Last Updated: 2015-12-22

Results Overview

Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Results posted on

2015-12-22

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1: BIA 9-1067 + Warfarin, Then Warfarin
Period 1: BIA 9-1067 + warfarin Period 2: warfarin BIA 9-1067: BIA 9-1067 25 mg Warfarin: Warfarin 25 mg
Group 2: Warfarin, Then BIA 9-1067 + Warfarin
Period 1: warfarin Period 2: BIA 9-1067 + warfarin BIA 9-1067: BIA 9-1067 25 mg Warfarin: Warfarin 25 mg
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1: BIA 9-1067 + Warfarin, Then Warfarin
n=10 Participants
Period 1: BIA 9-1067 + warfarin Period 2: warfarin BIA 9-1067: BIA 9-1067 25 mg Warfarin: Warfarin 25 mg
Group 2: Warfarin, Then BIA 9-1067 + Warfarin
n=10 Participants
Period 1: warfarin Period 2: BIA 9-1067 + warfarin BIA 9-1067: BIA 9-1067 25 mg Warfarin: Warfarin 25 mg
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)
196 ng/mL
Standard Deviation 106

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)
3.00 hours
Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)
610 ng.h/mL
Standard Deviation 420

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Cmax = Maximum Plasma Concentration (Warfarin Alone)
1940 ng/mL
Standard Deviation 364

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)
2.50 hours
Interval 0.5 to 16.0

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)
75098 ng.h/mL
Standard Deviation 13792

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)
2003 ng/mL
Standard Deviation 392

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)
3.00 hours
Interval 0.5 to 8.0

PRIMARY outcome

Timeframe: before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.

Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067

Outcome measures

Outcome measures
Measure
BIA 9-1067 + Warfarin
n=20 Participants
BIA 9-1067 25 mg + Warfarin 25 mg
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)
78177 ng.h/mL
Standard Deviation 15196

Adverse Events

BIA 9-1067 + Warfarin

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Warfarin

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
BIA 9-1067 + Warfarin
n=20 participants at risk
BIA 9-1067 25 mg Warfarin 25 mg
Warfarin
n=20 participants at risk
Warfarin 25 mg
Eye disorders
Blepharitis
0.00%
0/20
5.0%
1/20
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/20
5.0%
1/20
Gastrointestinal disorders
Gingival bleeding
0.00%
0/20
5.0%
1/20
Injury, poisoning and procedural complications
Vessel puncture site haematoma
0.00%
0/20
5.0%
1/20
Investigations
Blood creatine phosphokinase increased
10.0%
2/20
5.0%
1/20
Metabolism and nutrition disorders
Decreased appetite
5.0%
1/20
0.00%
0/20
Nervous system disorders
Dizziness
5.0%
1/20
0.00%
0/20
Nervous system disorders
Headache
5.0%
1/20
5.0%
1/20
Nervous system disorders
Hypoaesthesia
5.0%
1/20
0.00%
0/20
Nervous system disorders
Presyncope
5.0%
1/20
5.0%
1/20
Reproductive system and breast disorders
Metrorrhagia
5.0%
1/20
0.00%
0/20
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
5.0%
1/20
0.00%
0/20
Vascular disorders
Haematoma
0.00%
0/20
5.0%
1/20

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Results disclosure agreements

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