Trial Outcomes & Findings for Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone (NCT NCT02305316)
NCT ID: NCT02305316
Last Updated: 2015-08-21
Results Overview
Maximum observed plasma concentration of BIA 9-1067
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Results posted on
2015-08-21
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 Non-micronized - Micronized
Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized
|
BIA 9-1067 Micronized - Non-micronized
Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Baseline characteristics by cohort
| Measure |
BIA 9-1067 Non-micronized - Micronized
n=14 Participants
Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized
|
BIA 9-1067 Micronized - Non-micronized
n=14 Participants
Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
BIA 9-1067 non-micronized
BIA 9-1067 micronized
|
Total
n=28 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
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.Maximum observed plasma concentration of BIA 9-1067
Outcome measures
| Measure |
BIA 9-1067 Non-micronized
n=28 Participants
BIA 9-1067 non-micronized.
|
BIA 9-1067 Micronized
n=28 Participants
BIA 9-1067 micronized.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
327.8 ng/mL
Standard Deviation 129.6
|
750.1 ng/mL
Standard Deviation 184.1
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067
Outcome measures
| Measure |
BIA 9-1067 Non-micronized
n=28 Participants
BIA 9-1067 non-micronized.
|
BIA 9-1067 Micronized
n=28 Participants
BIA 9-1067 micronized.
|
|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration
|
1152.8 ng.h/mL
Standard Deviation 537.5
|
2296.5 ng.h/mL
Standard Deviation 778.2
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067
Outcome measures
| Measure |
BIA 9-1067 Non-micronized
n=28 Participants
BIA 9-1067 non-micronized.
|
BIA 9-1067 Micronized
n=28 Participants
BIA 9-1067 micronized.
|
|---|---|---|
|
Tmax - Time of Occurrence of Cmax of BIA 9-1067
|
2.50 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.
Outcome measures
| Measure |
BIA 9-1067 Non-micronized
n=28 Participants
BIA 9-1067 non-micronized.
|
BIA 9-1067 Micronized
n=28 Participants
BIA 9-1067 micronized.
|
|---|---|---|
|
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity
|
1327.0 ng.h/mL
Standard Deviation 562.0
|
2324.1 ng.h/mL
Standard Deviation 781.8
|
Adverse Events
BIA 9-1067 Non-micronized
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BIA 9-1067 Micronized
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 9-1067 Non-micronized
n=28 participants at risk
BIA 9-1067 non-micronized.
|
BIA 9-1067 Micronized
n=28 participants at risk
BIA 9-1067 micronized.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.1%
2/28
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
0.00%
0/28
|
3.6%
1/28
|
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