Trial Outcomes & Findings for A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers (NCT NCT01879345)
NCT ID: NCT01879345
Last Updated: 2025-04-08
Results Overview
investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
3 weeks
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
BIA 2-093 - 1800 mg (Group 1)
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
PLC, Placebo
|
|---|---|---|---|
|
Single-dose Period
STARTED
|
6
|
6
|
6
|
|
Single-dose Period
COMPLETED
|
6
|
6
|
6
|
|
Single-dose Period
NOT COMPLETED
|
0
|
0
|
0
|
|
7-day Multiple-dose Period
STARTED
|
6
|
6
|
6
|
|
7-day Multiple-dose Period
COMPLETED
|
6
|
6
|
6
|
|
7-day Multiple-dose Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 Participants
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 Participants
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
n=6 Participants
PLC, Placebo
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 3 weeksinvestigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient
Outcome measures
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 Participants
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 Participants
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
n=6 Participants
PLC, Placebo
|
|---|---|---|---|
|
Number of Adverse Events Reported
|
10 Number of adverse events reported
|
7 Number of adverse events reported
|
7 Number of adverse events reported
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
Outcome measures
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 Participants
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 Participants
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
PLC, Placebo
|
|---|---|---|---|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (oxcarbazepine) single dose
|
241 ng/mL
Standard Deviation 57.1
|
508 ng/mL
Standard Deviation 177
|
—
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (BIA 2-005) single dose
|
34569 ng/mL
Standard Deviation 5623
|
35926 ng/mL
Standard Deviation 15301
|
—
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (BIA 2-005) multiple dose
|
47665 ng/mL
Standard Deviation 11108
|
56506 ng/mL
Standard Deviation 11277
|
—
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (oxcarbazepine) multiple dose
|
361 ng/mL
Standard Deviation 106
|
734 ng/mL
Standard Deviation 186
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
Outcome measures
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 Participants
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 Participants
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
PLC, Placebo
|
|---|---|---|---|
|
Tmax - the Time of Occurrence of Cmax
tmax (BIA 2-005) single dose
|
3.8 hours
Standard Deviation 1.2
|
3.3 hours
Standard Deviation 1.7
|
—
|
|
Tmax - the Time of Occurrence of Cmax
tmax (BIA 2-005) multiple dose
|
2.1 hours
Standard Deviation 1.2
|
3.6 hours
Standard Deviation 2.7
|
—
|
|
Tmax - the Time of Occurrence of Cmax
tmax (oxcarbazepine) single dose
|
4.67 hours
Standard Deviation 1.03
|
4.00 hours
Standard Deviation 1.10
|
—
|
|
Tmax - the Time of Occurrence of Cmax
tmax (oxcarbazepine) multiple dose
|
3.83 hours
Standard Deviation 1.17
|
3.67 hours
Standard Deviation 0.52
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
Outcome measures
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 Participants
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 Participants
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
PLC, Placebo
|
|---|---|---|---|
|
AUC0-τ
AUC0-τ (BIA 2-005) single dose
|
507563 ng.h/mL
Standard Deviation 86363
|
445596 ng.h/mL
Standard Deviation 116306
|
—
|
|
AUC0-τ
AUC0-τ (BIA 2-005) multiple dose
|
740299 ng.h/mL
Standard Deviation 144882
|
905860 ng.h/mL
Standard Deviation 115783
|
—
|
|
AUC0-τ
AUC0-τ (oxcarbazepine) single dose
|
3589 ng.h/mL
Standard Deviation 847
|
4547 ng.h/mL
Standard Deviation 1512
|
—
|
|
AUC0-τ
AUC0-τ (oxcarbazepine) multiple dose
|
6958 ng.h/mL
Standard Deviation 1824
|
9956 ng.h/mL
Standard Deviation 2329
|
—
|
Adverse Events
BIA 2-093 - 1800 mg (Group 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BIA 2-093 - 2400 mg (Group 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 - 1800 mg (Group 1)
n=6 participants at risk
3 tablets of BIA 2-093 600 mg
BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093
|
BIA 2-093 - 2400 mg (Group 2)
n=6 participants at risk
4 tablets of BIA 2-093 600 mg
BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg
|
Placebo
n=6 participants at risk
PLC, Placebo
|
|---|---|---|---|
|
Eye disorders
Photopsia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Eye disorders
Rhinoconjunctivitis
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Visual disturbance
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Catheter site ecchymosis
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Catheter site phlebitis
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood pressure increased
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Investigations
Opticokinetic nystagmus tests abdnormal
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Paraesthesia circumoral
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Nervous system disorders
Pre-syncope
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
|
Nervous system disorders
Tremor of hands
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
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