Trial Outcomes & Findings for An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 (NCT NCT02281422)
NCT ID: NCT02281422
Last Updated: 2014-12-31
Results Overview
BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.
Results posted on
2014-12-31
Participant Flow
Participant milestones
| Measure |
Group 1 Normal Renal Function
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Baseline characteristics by cohort
| Measure |
Group 1 Normal Renal Function
n=8 Participants
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
n=8 Participants
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
n=8 Participants
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
n=8 Participants
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
n=8 Participants
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
Total
n=40 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites
Outcome measures
| Measure |
Group 1 Normal Renal Function
n=8 Participants
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
n=8 Participants
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
n=8 Participants
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
n=8 Participants
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
n=8 Participants
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
|---|---|---|---|---|---|
|
Cmax - Peak Plasma Concentration
Cmax (BIA 2-194)
|
14286.790 ng/mL
Standard Deviation 2988.340
|
18677.265 ng/mL
Standard Deviation 4381.474
|
15055.632 ng/mL
Standard Deviation 2513.170
|
14974.79 ng/mL
Standard Deviation 4313.90
|
14510.197 ng/mL
Standard Deviation 2149.176
|
|
Cmax - Peak Plasma Concentration
Cmax (BIA 2-195)
|
211.076 ng/mL
Standard Deviation 61.0200
|
348.843 ng/mL
Standard Deviation 69.739
|
410.828 ng/mL
Standard Deviation 68.663
|
465.928 ng/mL
Standard Deviation 201.988
|
359.798 ng/mL
Standard Deviation 119.819
|
|
Cmax - Peak Plasma Concentration
Cmax (Oxcarbazepine)
|
138.339 ng/mL
Standard Deviation 32.271
|
172.293 ng/mL
Standard Deviation 43.431
|
157.629 ng/mL
Standard Deviation 35.224
|
157.955 ng/mL
Standard Deviation 61.354
|
208.473 ng/mL
Standard Deviation 40.912
|
PRIMARY outcome
Timeframe: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites AUC - area under the plasma concentration versus time curve
Outcome measures
| Measure |
Group 1 Normal Renal Function
n=8 Participants
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
n=8 Participants
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
n=8 Participants
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
n=8 Participants
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
n=8 Participants
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
|---|---|---|---|---|---|
|
AUC(0-12h) - AUC From Time Zero to 12h
AUC(0-12h) (BIA 2-194)
|
105275.733 ng*h/mL
Standard Deviation 21516.315
|
150945.034 ng*h/mL
Standard Deviation 24049.320
|
138473.115 ng*h/mL
Standard Deviation 19998.869
|
138262.814 ng*h/mL
Standard Deviation 43286.475
|
134757.936 ng*h/mL
Standard Deviation 18609.384
|
|
AUC(0-12h) - AUC From Time Zero to 12h
AUC(0-12h) (BIA 2-195)
|
1522.370 ng*h/mL
Standard Deviation 427.4400
|
2435.245 ng*h/mL
Standard Deviation 681.175
|
2025.731 ng*h/mL
Standard Deviation 419.930
|
2157.860 ng*h/mL
Standard Deviation 1092.304
|
2690.584 ng*h/mL
Standard Deviation 731.793
|
|
AUC(0-12h) - AUC From Time Zero to 12h
AUC(0-12h) (Oxcarbazepine)
|
1218.276 ng*h/mL
Standard Deviation 279.550
|
1388.146 ng*h/mL
Standard Deviation 316.857
|
1460.113 ng*h/mL
Standard Deviation 351.507
|
1496.463 ng*h/mL
Standard Deviation 653.928
|
1832.298 ng*h/mL
Standard Deviation 338.896
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites Cmax - maximum observed plasma drug concentration
Outcome measures
| Measure |
Group 1 Normal Renal Function
n=8 Participants
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
n=8 Participants
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
n=8 Participants
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
n=8 Participants
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
n=8 Participants
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
|---|---|---|---|---|---|
|
Tmax (hr) - Time at Which Cmax Occurred
Tmax (BIA 2-194)
|
1.121 hours
Standard Deviation 0.530
|
1.327 hours
Standard Deviation 1.004
|
2.609 hours
Standard Deviation 2.504
|
2.680 hours
Standard Deviation 2.642
|
1.633 hours
Standard Deviation 1.069
|
|
Tmax (hr) - Time at Which Cmax Occurred
Tmax (BIA 2-195)
|
22.008 hours
Standard Deviation 4.2430
|
20.185 hours
Standard Deviation 5.557
|
26.172 hours
Standard Deviation 8.485
|
33.947 hours
Standard Deviation 12.824
|
10.773 hours
Standard Deviation 1.553
|
|
Tmax (hr) - Time at Which Cmax Occurred
Tmax (Oxcarbazepine)
|
2.396 hours
Standard Deviation 0.773
|
2.581 hours
Standard Deviation 0.681
|
3.970 hours
Standard Deviation 2.397
|
4.787 hours
Standard Deviation 3.172
|
4.260 hours
Standard Deviation 2.254
|
Adverse Events
Group 1 Normal Renal Function
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 Mild Renal Impairment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3 Moderate Renal Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4 Severe Renal Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 5 End Stage Renal Disease
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Normal Renal Function
n=8 participants at risk
normal renal function (creatinine clearance \> 80 mL/min)
BIA 2-093
|
Group 2 Mild Renal Impairment
n=8 participants at risk
mild renal impairment (creatinine clearance 50-80 mL/min)
BIA 2-093
|
Group 3 Moderate Renal Impairment
n=8 participants at risk
moderate renal impairment (creatinine clearance 30-50 mL/min)
BIA 2-093
|
Group 4 Severe Renal Impairment
n=8 participants at risk
severe renal impairment (creatinine clearance \<30 mL/min)
BIA 2-093
|
Group 5 End Stage Renal Disease
n=8 participants at risk
end stage renal disease, requiring haemodialysis (ESRD)
BIA 2-093
|
|---|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
62.5%
5/8
|
37.5%
3/8
|
25.0%
2/8
|
12.5%
1/8
|
12.5%
1/8
|
|
Nervous system disorders
SOMNOLENCE
|
12.5%
1/8
|
37.5%
3/8
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8
|
12.5%
1/8
|
0.00%
0/8
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
FATIGUE
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Reproductive system and breast disorders
GENITAL PRURITUS FEMALE
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
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