Trial Outcomes & Findings for An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 (NCT NCT02281526)
NCT ID: NCT02281526
Last Updated: 2015-01-12
Results Overview
Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast). BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
Subjects With Moderate Hepatic Impairment
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Baseline characteristics by cohort
| Measure |
Subjects With Moderate Hepatic Impairment
n=9 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
n=8 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Total
n=17 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
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast). BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites.
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment
n=8 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
n=8 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) BIA 2-093
|
954.891 h·ng/mL
Standard Deviation 963.751
|
49.750 h·ng/mL
Standard Deviation 27.931
|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) BIA 2-194
|
240188.369 h·ng/mL
Standard Deviation 27773.762
|
234750.429 h·ng/mL
Standard Deviation 31036.558
|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) 2-195 Glucoronide
|
50.603 h·ng/mL
Standard Deviation 44.226
|
157.738 h·ng/mL
Standard Deviation 199.859
|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) Oxcarbazepine
|
1489.530 h·ng/mL
Standard Deviation 1055.930
|
1899.092 h·ng/mL
Standard Deviation 915.761
|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) BIA 2-093 Glucoronide
|
6.875 h·ng/mL
Standard Deviation 2.312
|
2.500 h·ng/mL
Standard Deviation 2.500
|
|
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
AUC(0-tlast) BIA 2-194 Glucoronide
|
8634.780 h·ng/mL
Standard Deviation 5915.045
|
11642.372 h·ng/mL
Standard Deviation 11102.059
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.Day 1 - Cmax Peak plasma concentration
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment
n=8 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
n=8 Participants
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
|---|---|---|
|
Cmax - Peak Plasma Concentration
Cmax BIA 2-093
|
477.500 ng/mL
Standard Deviation 439.131
|
99.500 ng/mL
Standard Deviation 55.861
|
|
Cmax - Peak Plasma Concentration
Cmax BIA 2-194
|
16392.778 ng/mL
Standard Deviation 3508.757
|
18180.000 ng/mL
Standard Deviation 1996.970
|
|
Cmax - Peak Plasma Concentration
Cmax 2-195 Glucoronide
|
16.875 ng/mL
Standard Deviation 19.045
|
16.667 ng/mL
Standard Deviation 15.539
|
|
Cmax - Peak Plasma Concentration
Cmax Oxcarbazepine
|
100.111 ng/mL
Standard Deviation 51.948
|
121.000 ng/mL
Standard Deviation 63.042
|
|
Cmax - Peak Plasma Concentration
Cmax BIA 2-093 Glucoronide
|
9.000 ng/mL
Standard Deviation 2.449
|
5.000 ng/mL
Standard Deviation 5.000
|
|
Cmax - Peak Plasma Concentration
Cmax BIA 2-194 Glucoronide
|
1067.000 ng/mL
Standard Deviation 517.493
|
1381.125 ng/mL
Standard Deviation 973.778
|
Adverse Events
Subjects With Moderate Hepatic Impairment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Subjects - Healthy Controls
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With Moderate Hepatic Impairment
n=9 participants at risk
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
n=8 participants at risk
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
|---|---|---|
|
Metabolism and nutrition disorders
hepatic encephalopathy
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
Subjects With Moderate Hepatic Impairment
n=9 participants at risk
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
Subjects - Healthy Controls
n=8 participants at risk
This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
BIA 2-093
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
33.3%
3/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
NAUSEA
|
22.2%
2/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
VOMITING
|
66.7%
6/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/9
|
12.5%
1/8
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.1%
1/9
|
0.00%
0/8
|
|
Nervous system disorders
HEADACHE
|
11.1%
1/9
|
37.5%
3/8
|
|
Nervous system disorders
DIZZINESS
|
22.2%
2/9
|
0.00%
0/8
|
|
General disorders
FATIGUE
|
0.00%
0/9
|
37.5%
3/8
|
|
General disorders
CHILLS
|
11.1%
1/9
|
0.00%
0/8
|
|
General disorders
PYREXIA
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.1%
1/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
11.1%
1/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
11.1%
1/9
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
SCRATCH
|
11.1%
1/9
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
WOUND
|
22.2%
2/9
|
0.00%
0/8
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
11.1%
1/9
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.1%
1/9
|
0.00%
0/8
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER