Trial Outcomes & Findings for Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (NCT NCT01678976)
NCT ID: NCT01678976
Last Updated: 2015-01-08
Results Overview
Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
Period 1 - BIA 2-093; Period 2 - Oxcarbazepine
Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
|
Period 1 - Oxcarbazepine; Period 2 - BIA 2-093
Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
|
|---|---|---|
|
First Period
STARTED
|
6
|
7
|
|
First Period
COMPLETED
|
6
|
6
|
|
First Period
NOT COMPLETED
|
0
|
1
|
|
Second Period
STARTED
|
6
|
6
|
|
Second Period
COMPLETED
|
6
|
6
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Period 1 - BIA 2-093; Period 2 - Oxcarbazepine
n=6 Participants
Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
|
Period 1 - Oxcarbazepine; Period 2 - BIA 2-093
n=6 Participants
Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dosePopulation: Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.
Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=6 Participants
BIA 2-093, ESL Eslicarbazepine acetate
|
Oxcarbazepine 900 mg od
n=6 Participants
Oxcarbazepine, Trileptal®
|
|---|---|---|
|
Maximum Drug Concentration (Cmax)
Cmax (BIA 2-194)
|
15753 ng/mL
Standard Deviation 3781
|
5978 ng/mL
Standard Deviation 1136
|
|
Maximum Drug Concentration (Cmax)
Cmax (BIA 2-195)
|
428 ng/mL
Standard Deviation 88.6
|
1708 ng/mL
Standard Deviation 751
|
|
Maximum Drug Concentration (Cmax)
Cmax (Oxcarbazepine)
|
140 ng/mL
Standard Deviation 37.7
|
1268 ng/mL
Standard Deviation 656
|
SECONDARY outcome
Timeframe: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dosePopulation: Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.
Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=6 Participants
BIA 2-093, ESL Eslicarbazepine acetate
|
Oxcarbazepine 900 mg od
n=6 Participants
Oxcarbazepine, Trileptal®
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC0-t (BIA 2-194)
|
299065 ng*h/mL
Standard Deviation 65077
|
214433 ng*h/mL
Standard Deviation 45162
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC0-t (BIA 2-195)
|
13877 ng*h/mL
Standard Deviation 2867
|
49124 ng*h/mL
Standard Deviation 18926
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC0-t (Oxcarbazepine)
|
1821 ng*h/mL
Standard Deviation 693
|
6549 ng*h/mL
Standard Deviation 3927
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksMonitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient
Outcome measures
| Measure |
BIA 2-093 900 mg od
n=12 Participants
BIA 2-093, ESL Eslicarbazepine acetate
|
Oxcarbazepine 900 mg od
n=13 Participants
Oxcarbazepine, Trileptal®
|
|---|---|---|
|
Total of Subjects Reporting at Least One Adverse Event
Possibly related to treatment AEs
|
5 subjects reporting at least 1 AE
|
4 subjects reporting at least 1 AE
|
|
Total of Subjects Reporting at Least One Adverse Event
All treatment-emergent AEs
|
6 subjects reporting at least 1 AE
|
6 subjects reporting at least 1 AE
|
Adverse Events
BIA 2-093
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Oxcarbazepine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093
n=12 participants at risk
BIA 2-093, ESL, Eslicarbazepine
|
Oxcarbazepine
n=13 participants at risk
Oxcarbazepine, Trileptal
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
41.7%
5/12
|
23.1%
3/13
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
23.1%
3/13
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12
|
15.4%
2/13
|
|
Nervous system disorders
Concentration impairment
|
16.7%
2/12
|
0.00%
0/13
|
|
Nervous system disorders
Lipothymia
|
8.3%
1/12
|
0.00%
0/13
|
|
Nervous system disorders
Nystagmus NOS
|
16.7%
2/12
|
0.00%
0/13
|
|
Nervous system disorders
Parasthesiae circumoral
|
16.7%
2/12
|
0.00%
0/13
|
|
Nervous system disorders
Taste bitter
|
16.7%
2/12
|
0.00%
0/13
|
|
Nervous system disorders
Thinking reduced
|
0.00%
0/12
|
15.4%
2/13
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/12
|
7.7%
1/13
|
|
Gastrointestinal disorders
Toothache
|
25.0%
3/12
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
8.3%
1/12
|
0.00%
0/13
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12
|
0.00%
0/13
|
|
General disorders
Application site bruise
|
0.00%
0/12
|
7.7%
1/13
|
|
General disorders
Fatigue
|
16.7%
2/12
|
0.00%
0/13
|
|
General disorders
Venipuncture site bruise
|
8.3%
1/12
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
8.3%
1/12
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat NOS
|
8.3%
1/12
|
7.7%
1/13
|
|
Ear and labyrinth disorders
Sensation of pressure in ear
|
0.00%
0/12
|
15.4%
2/13
|
|
Investigations
CPK increased
|
0.00%
0/12
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Nodule subcutaneous
|
0.00%
0/12
|
15.4%
2/13
|
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