Trial Outcomes & Findings for Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (NCT NCT01679002)
NCT ID: NCT01679002
Last Updated: 2025-04-06
Results Overview
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Group A
BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.
BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
|
Group B
BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od
|
Group C
oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
BIA 2-093 900 mg Once-daily Period
|
4
|
3
|
4
|
|
Overall Study
BIA 2-093 450 mg Twice-daily Period
|
4
|
4
|
4
|
|
Overall Study
Oxcarbazepine 450 mg Twice-daily Period
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A
BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.
BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
|
Group B
BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od
|
Group C
oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Group A
n=4 Participants
BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
|
Group B
n=4 Participants
BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
|
Group C
n=4 Participants
oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
|
Total
n=12 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dosePopulation: The results are related to overall population in the study devided by period of treatment.
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=11 Participants
ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
|
BIA 2-093 450 mg Bid
n=11 Participants
ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
|
Oxcarbazepine 450 mg Bid
n=11 Participants
OXC, Oxcarbazepine 450 mg bid
|
|---|---|---|---|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (BIA 2-194)
|
22210 ng/mL
Standard Deviation 7257
|
16667 ng/mL
Standard Deviation 3981
|
12195 ng/mL
Standard Deviation 2053
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (BIA 2-195)
|
685 ng/mL
Standard Deviation 188
|
702 ng/mL
Standard Deviation 182
|
2481 ng/mL
Standard Deviation 362
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Cmax (Oxcarbazepine)
|
208 ng/mL
Standard Deviation 53.2
|
182 ng/mL
Standard Deviation 47.2
|
1080 ng/mL
Standard Deviation 548
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dosePopulation: The results are related to overall population in the study devided by period of treatment.
AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=11 Participants
ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
|
BIA 2-093 450 mg Bid
n=11 Participants
ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
|
Oxcarbazepine 450 mg Bid
n=11 Participants
OXC, Oxcarbazepine 450 mg bid
|
|---|---|---|---|
|
AUC - Area Under the Plasma Concentration Versus Time Curve
AUC0-t (BIA 2-194)
|
381601 ng*h/mL
Standard Deviation 95368
|
283014 ng*h/mL
Standard Deviation 74203
|
268376 ng*h/mL
Standard Deviation 43294
|
|
AUC - Area Under the Plasma Concentration Versus Time Curve
AUC0-t (BIA 2-195)
|
20164 ng*h/mL
Standard Deviation 6790
|
19091 ng*h/mL
Standard Deviation 6042
|
48841 ng*h/mL
Standard Deviation 9041
|
|
AUC - Area Under the Plasma Concentration Versus Time Curve
AUC0-t (Oxcarbazepine)
|
3238 ng*h/mL
Standard Deviation 1033
|
2699 ng*h/mL
Standard Deviation 909
|
5196 ng*h/mL
Standard Deviation 1472
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The results are related to overall population in the study devided by period of treatment.
Number of of subjects reporting at least one adverse event.
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=11 Participants
ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
|
BIA 2-093 450 mg Bid
n=12 Participants
ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
|
Oxcarbazepine 450 mg Bid
n=11 Participants
OXC, Oxcarbazepine 450 mg bid
|
|---|---|---|---|
|
Number of of Subjects Reporting at Least One Adverse Event
|
9 Subjects
|
10 Subjects
|
11 Subjects
|
Adverse Events
BIA 2-093 900 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BIA 2-093 450 mg Bid
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Oxcarbazepine 450 mg Bid
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 900 mg
n=11 participants at risk
ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
|
BIA 2-093 450 mg Bid
n=12 participants at risk
ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
|
Oxcarbazepine 450 mg Bid
n=11 participants at risk
OXC, Oxcarbazepine 450 mg bid
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
1/11
|
8.3%
1/12
|
9.1%
1/11
|
|
Nervous system disorders
Nystagmus
|
18.2%
2/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Nervous system disorders
Orthostatic dizziness
|
9.1%
1/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Diffuse macular rash
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Nervous system disorders
Migraine
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Nervous system disorders
Motor dysfunction NOS
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Nervous system disorders
Numbness of limbs
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Nervous system disorders
Occipital headache
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
0.00%
0/12
|
18.2%
2/11
|
|
Gastrointestinal disorders
Abdominal colic
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dry lips
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Epigastric pain
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Gastrointestinal disorders
Right upper quadrant pain
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Tooth pain
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11
|
16.7%
2/12
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Vascular disorders
Haematoma
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Nervous system disorders
Somnolence
|
27.3%
3/11
|
25.0%
3/12
|
54.5%
6/11
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
16.7%
2/12
|
54.5%
6/11
|
|
Nervous system disorders
Frontal headache
|
18.2%
2/11
|
8.3%
1/12
|
18.2%
2/11
|
|
General disorders
Asthenia
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
General disorders
Fatigue
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
General disorders
Injection site haematoma
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11
|
8.3%
1/12
|
9.1%
1/11
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11
|
16.7%
2/12
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Appetite lost
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
|
Eye disorders
Blepharospasm
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/11
|
|
Investigations
Transaminases increased
|
0.00%
0/11
|
8.3%
1/12
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
9.1%
1/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Psychiatric disorders
Increased libido
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11
|
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