Trial Outcomes & Findings for Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate (NCT NCT02288312)
NCT ID: NCT02288312
Last Updated: 2015-01-08
Results Overview
Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
Group A
Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)
Washout periods - 7 days between dosing days
|
Group B
Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)
Washout periods - 7 days between dosing days
|
Group C
Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)
Washout periods - 7 days between dosing days
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A
Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)
Washout periods - 7 days between dosing days
|
Group B
Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)
Washout periods - 7 days between dosing days
|
Group C
Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)
Washout periods - 7 days between dosing days
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
Baseline Characteristics
Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
Baseline characteristics by cohort
| Measure |
Sequence A
n=6 Participants
Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
|
Sequence B
n=6 Participants
Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
|
Sequence C
n=6 Participants
Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
|
Total
n=18 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)
Outcome measures
| Measure |
BIA 2-093 800 mg Fasting
n=18 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg Fed
n=17 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg (2 x 400 mg)
n=17 Participants
Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093
|
|---|---|---|---|
|
Cmax (BIA 2-005)
|
10973 ng/mL
Standard Deviation 2628
|
11044 ng/mL
Standard Deviation 2495
|
11022 ng/mL
Standard Deviation 2748
|
SECONDARY outcome
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)
Outcome measures
| Measure |
BIA 2-093 800 mg Fasting
n=18 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg Fed
n=17 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg (2 x 400 mg)
n=17 Participants
Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093
|
|---|---|---|---|
|
AUC0-t (BIA 2-005)
|
241651 ng.h/mL
Standard Deviation 50381
|
234092 ng.h/mL
Standard Deviation 50510
|
242375 ng.h/mL
Standard Deviation 48599
|
SECONDARY outcome
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)
Outcome measures
| Measure |
BIA 2-093 800 mg Fasting
n=18 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg Fed
n=17 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg (2 x 400 mg)
n=17 Participants
Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093
|
|---|---|---|---|
|
Tmax (BIA 2-005)
|
2.64 hours
Standard Deviation 1.65
|
2.75 hours
Standard Deviation 2.31
|
2.56 hours
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)
Outcome measures
| Measure |
BIA 2-093 800 mg Fasting
n=18 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg Fed
n=17 Participants
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg (2 x 400 mg)
n=17 Participants
Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093
|
|---|---|---|---|
|
AUC0-∞ (BIA 2-005)
|
243808 ng.h/mL
Standard Deviation 50464
|
236089 ng.h/mL
Standard Deviation 50764
|
244821 ng.h/mL
Standard Deviation 48873
|
Adverse Events
BIA 2-093 800 mg Fasting
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 2-093 800 mg Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BIA 2-093 800 mg (2 x 400 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 800 mg Fasting
n=18 participants at risk
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg Fed
n=17 participants at risk
Tablets 800 mg. Administration:Oral.
BIA 2-093
|
BIA 2-093 800 mg (2 x 400 mg)
n=17 participants at risk
Tablets 2 x 400 mg. Administration:Oral.
BIA 2-093
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/17
|
|
Infections and infestations
Tonsillitis
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/17
|
|
Investigations
CPK increased
|
0.00%
0/18
|
5.9%
1/17
|
5.9%
1/17
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18
|
5.9%
1/17
|
5.9%
1/17
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/18
|
5.9%
1/17
|
0.00%
0/17
|
|
Surgical and medical procedures
Tooth extraction
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/17
|
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