Trial Outcomes & Findings for Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment (NCT NCT02101190)
NCT ID: NCT02101190
Last Updated: 2015-01-15
Results Overview
BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Group 1 - Hepatic Impaired Subjects
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
Baseline characteristics by cohort
| Measure |
Group 1 - Hepatic Impaired Subjects
n=8 Participants
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
n=8 Participants
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Total
n=16 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-doseBIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067
Outcome measures
| Measure |
Group 1 - Hepatic Impaired Subjects
n=8 Participants
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
n=8 Participants
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
|---|---|---|
|
Cmax - Maximum Plasma Concentration of BIA 9-1067
|
1108 ng/mL
Standard Deviation 448
|
559 ng/mL
Standard Deviation 119
|
PRIMARY outcome
Timeframe: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-doseBIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067
Outcome measures
| Measure |
Group 1 - Hepatic Impaired Subjects
n=8 Participants
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
n=8 Participants
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
|---|---|---|
|
Tmax - Time to Reach Cmax
|
3.0 hours
Interval 1.5 to 4.0
|
3.0 hours
Interval 1.5 to 4.0
|
PRIMARY outcome
Timeframe: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-doseBIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067
Outcome measures
| Measure |
Group 1 - Hepatic Impaired Subjects
n=8 Participants
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
n=8 Participants
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
|---|---|---|
|
Area Under the Curve (AUC0-t)
|
3392 ng.hr/mL
Standard Deviation 1584
|
1724 ng.hr/mL
Standard Deviation 503
|
Adverse Events
Group 1 - Hepatic Impaired Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2 - Healthy Subjects
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 |
Group 1 - Hepatic Impaired Subjects
n=8 participants at risk
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
Group 2 - Healthy Subjects
n=8 participants at risk
Group 2 - healthy subjects treated with BIA 9-1067
BIA 9-1067: Opicapone, OPC
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
12.5%
1/8
|
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