Trial Outcomes & Findings for Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 (NCT NCT02279667)
NCT ID: NCT02279667
Last Updated: 2015-01-01
Results Overview
Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose
Results posted on
2015-01-01
Participant Flow
Participant milestones
| Measure |
Group A
1. st period - 16 mL oral suspension 50 mg/mL
2. nd period - Four 200 mg tablets
3. rd period - One 800 mg tablet
|
Group B
1. st period - One 800 mg tablet
2. nd period - 16 mL oral suspension 50 mg/mL
3. rd period - Four 200 mg tablets
|
Group C
1. st period - Four 200 mg tablets
2. nd period - One 800 mg tablet
3. rd period - 16 mL oral suspension 50 mg/mL
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Baseline characteristics by cohort
| Measure |
Group A
n=6 Participants
1. st period - 16 mL oral suspension 50 mg/mL
2. nd period - Four 200 mg tablets
3. rd period - One 800 mg tablet
|
Group B
n=6 Participants
1. st period - One 800 mg tablet
2. nd period - 16 mL oral suspension 50 mg/mL
3. rd period - Four 200 mg tablets
|
Group C
n=6 Participants
1. st period - Four 200 mg tablets
2. nd period - One 800 mg tablet
3. rd period - 16 mL oral suspension 50 mg/mL
|
Total
n=18 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-doseCmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Outcome measures
| Measure |
BIA 2-093 16 mL Oral Suspension 50 mg/mL
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
|
BIA 2-093 - Four 200 mg Tablets
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
|
BIA 2-093 One 800 mg Tablet
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
|
|---|---|---|---|
|
Cmax - the Maximum Plasma Concentration
|
18048 ng/mL
Standard Deviation 4644
|
16007 ng/mL
Standard Deviation 4008
|
17042 ng/mL
Standard Deviation 4131
|
PRIMARY outcome
Timeframe: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-doseTmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005
Outcome measures
| Measure |
BIA 2-093 16 mL Oral Suspension 50 mg/mL
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
|
BIA 2-093 - Four 200 mg Tablets
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
|
BIA 2-093 One 800 mg Tablet
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
|
|---|---|---|---|
|
Tmax - the Time of Occurrence of Cmax
|
2 hours
Interval 1.0 to 4.0
|
3 hours
Interval 1.5 to 6.0
|
3 hours
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-doseAUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005
Outcome measures
| Measure |
BIA 2-093 16 mL Oral Suspension 50 mg/mL
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
|
BIA 2-093 - Four 200 mg Tablets
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
|
BIA 2-093 One 800 mg Tablet
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
|
|---|---|---|---|
|
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
|
323277 ng*h/mL
Standard Deviation 64055
|
302026 ng*h/mL
Standard Deviation 65270
|
299016 ng*h/mL
Standard Deviation 58806
|
PRIMARY outcome
Timeframe: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-doseAUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005
Outcome measures
| Measure |
BIA 2-093 16 mL Oral Suspension 50 mg/mL
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
|
BIA 2-093 - Four 200 mg Tablets
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
|
BIA 2-093 One 800 mg Tablet
n=18 Participants
BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
|
|---|---|---|---|
|
AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
|
325732 ng*h/mL
Standard Deviation 64898
|
304219 ng*h/mL
Standard Deviation 66045
|
301065 ng*h/mL
Standard Deviation 59957
|
Adverse Events
BIA 2-093 16 mL Oral Suspension 50 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 2-093 - Four 200 mg Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 2-093 One 800 mg Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 16 mL Oral Suspension 50 mg/mL
n=18 participants at risk
BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
|
BIA 2-093 - Four 200 mg Tablets
n=18 participants at risk
BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
|
BIA 2-093 One 800 mg Tablet
n=18 participants at risk
BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
|
Follow-up
n=18 participants at risk
Follow-up.
|
|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
5.6%
1/18
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Investigations
CPK increased
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Nervous system disorders
Drowsiness
|
11.1%
2/18
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Nervous system disorders
Migraine type headaches
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Localized erythema
|
0.00%
0/18
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Vascular disorders
Facial flushing
|
5.6%
1/18
|
5.6%
1/18
|
0.00%
0/18
|
0.00%
0/18
|
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