Trial Outcomes & Findings for Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide (NCT NCT01533116)
NCT ID: NCT01533116
Last Updated: 2015-11-16
Results Overview
Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h
Results posted on
2015-11-16
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=13 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=13 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
Total
n=52 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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
52 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hPopulation: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=12 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=12 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration
Cmax (3-OMD) Prolopa® 100/25
|
688 ng/mL
Standard Deviation 230
|
360 ng/mL
Standard Deviation 96
|
206 ng/mL
Standard Deviation 110.8
|
160 ng/mL
Standard Deviation 61.9
|
|
Cmax - Maximum Plasma Concentration
Cmax (3-OMD) Sinemet® 100/25
|
456 ng/mL
Standard Deviation 130
|
307 ng/mL
Standard Deviation 106
|
167 ng/mL
Standard Deviation 82.5
|
115 ng/mL
Standard Deviation 54.5
|
|
Cmax - Maximum Plasma Concentration
Cmax (Levodopa) Sinemet® 100/25
|
985 ng/mL
Standard Deviation 290
|
1245 ng/mL
Standard Deviation 524
|
1200 ng/mL
Standard Deviation 607
|
944 ng/mL
Standard Deviation 256
|
|
Cmax - Maximum Plasma Concentration
Cmax (Levodopa) Prolopa® 100-25
|
1704 ng/mL
Standard Deviation 682
|
2100 ng/mL
Standard Deviation 907
|
1727 ng/mL
Standard Deviation 957
|
1795 ng/mL
Standard Deviation 788
|
|
Cmax - Maximum Plasma Concentration
Cmax (BIA 9-1067) Sinemet® 100/25
|
NA ng/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
75.0 ng/mL
Standard Deviation 39
|
263 ng/mL
Standard Deviation 82.3
|
310 ng/mL
Standard Deviation 115
|
|
Cmax - Maximum Plasma Concentration
Cmax (BIA 9-1067) Prolopa® 100/25
|
NA ng/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
95.5 ng/mL
Standard Deviation 41.1
|
281 ng/mL
Standard Deviation 153.4
|
370 ng/mL
Standard Deviation 181.7
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hPopulation: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=12 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=12 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (Levodopa) Sinemet® 100/25
|
0.5 hours
Interval 0.5 to 3.0
|
0.75 hours
Interval 0.5 to 3.0
|
0.5 hours
Interval 0.5 to 1.5
|
1.0 hours
Interval 0.5 to 2.0
|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (Levodopa) Prolopa® 100-25
|
1.0 hours
Interval 0.5 to 2.0
|
1.0 hours
Interval 0.5 to 1.5
|
1.0 hours
Interval 0.5 to 2.0
|
1.0 hours
Interval 0.5 to 2.0
|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (3-OMD) Sinemet® 100/25
|
4.0 hours
Interval 4.0 to 6.0
|
8.0 hours
Interval 6.0 to 8.0
|
6.0 hours
Interval 3.0 to 8.0
|
8.0 hours
Interval 4.0 to 8.0
|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (3-OMD) Prolopa® 100/25
|
4.0 hours
Interval 3.0 to 6.0
|
8.0 hours
Interval 4.0 to 8.0
|
6.0 hours
Interval 2.0 to 8.0
|
4.0 hours
Interval 3.0 to 8.0
|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (BIA 9-1067) Prolopa® 100/25
|
NA hours
BIA 9-1067 was not administered
|
3.0 hours
Interval 1.0 to 4.0
|
2.5 hours
Interval 0.5 to 6.0
|
3.0 hours
Interval 1.0 to 6.0
|
|
Tmax - Time to Maximum Plasma Concentration
Tmax (BIA 9-1067) Sinemet® 100/25
|
NA hours
BIA 9-1067 was not administered
|
1.5 hours
Interval 0.5 to 6.0
|
3.0 hours
Interval 1.5 to 6.0
|
4.0 hours
Interval 1.5 to 6.0
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hPopulation: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=12 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=12 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (Levodopa) Sinemet® 100/25
|
1837 ng.h/mL
Standard Deviation 593
|
3386 ng.h/mL
Standard Deviation 1449
|
2952 ng.h/mL
Standard Deviation 1003
|
2753 ng.h/mL
Standard Deviation 889
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (3-OMD) Prolopa® 100/25
|
11371 ng.h/mL
Standard Deviation 3707
|
6205 ng.h/mL
Standard Deviation 1458
|
3473 ng.h/mL
Standard Deviation 1962
|
2623 ng.h/mL
Standard Deviation 1065
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (BIA 9-1067) Sinemet® 100/25
|
NA ng.h/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
223 ng.h/mL
Standard Deviation 58.2
|
872 ng.h/mL
Standard Deviation 412
|
1101 ng.h/mL
Standard Deviation 525
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (BIA 9-1067) Prolopa® 100/25
|
NA ng.h/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
232 ng.h/mL
Standard Deviation 82.4
|
836 ng.h/mL
Standard Deviation 497
|
1185 ng.h/mL
Standard Deviation 562
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (Levodopa) Prolopa® 100-25
|
2438 ng.h/mL
Standard Deviation 712
|
4115 ng.h/mL
Standard Deviation 1547
|
3442 ng.h/mL
Standard Deviation 1225
|
4056 ng.h/mL
Standard Deviation 1051
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
AUC0-t (3-OMD) Sinemet® 100/25
|
7631 ng.h/mL
Standard Deviation 1786
|
5147 ng.h/mL
Standard Deviation 1534
|
2836 ng.h/mL
Standard Deviation 1495
|
1751 ng.h/mL
Standard Deviation 988
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hPopulation: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=12 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=12 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity
|
8.12 hours
Standard Deviation 8.15
|
2.71 hours
Standard Deviation 2.16
|
4.67 hours
Standard Deviation 1.92
|
3.50 hours
Standard Deviation 2.41
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hPopulation: According to the protocol, the "pharmacokinetic population" should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)
AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=12 Participants
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=12 Participants
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 Participants
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose
|
906 pmol/mg Hb/h.h
Standard Deviation 276
|
454 pmol/mg Hb/h.h
Standard Deviation 97.3
|
319 pmol/mg Hb/h.h
Standard Deviation 134
|
226 pmol/mg Hb/h.h
Standard Deviation 177
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
5 mg BIA 9-1067
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
15 mg BIA 9-1067
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
30 mg BIA 9-1067
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.
Placebo
levodopa/carbidopa
levodopa/benserazide
|
5 mg BIA 9-1067
n=13 participants at risk
5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
15 mg BIA 9-1067
n=13 participants at risk
15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
30 mg BIA 9-1067
n=12 participants at risk
30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
BIA 9-1067
levodopa/carbidopa
levodopa/benserazide
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Eye disorders
Dark circles under eyes
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Eye disorders
Eye pain
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Eye disorders
Eye pruritus
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Eye disorders
Ocular hyperaemia
|
7.1%
1/14
|
7.7%
1/13
|
15.4%
2/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
|
15.4%
2/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14
|
15.4%
2/13
|
15.4%
2/13
|
8.3%
1/12
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14
|
7.7%
1/13
|
7.7%
1/13
|
8.3%
1/12
|
|
General disorders
Chest discomfort
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
8.3%
1/12
|
|
General disorders
Chills
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
General disorders
Fatigue
|
7.1%
1/14
|
0.00%
0/13
|
15.4%
2/13
|
8.3%
1/12
|
|
General disorders
Feeling hot
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
8.3%
1/12
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Blood potassium increased
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
16.7%
2/12
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14
|
23.1%
3/13
|
7.7%
1/13
|
8.3%
1/12
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
14.3%
2/14
|
7.7%
1/13
|
7.7%
1/13
|
25.0%
3/12
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence
|
35.7%
5/14
|
23.1%
3/13
|
38.5%
5/13
|
50.0%
6/12
|
|
Psychiatric disorders
Euphoric mood
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Renal and urinary disorders
Polyuria
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Renal and urinary disorders
Urine odour abnormal
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
1/14
|
7.7%
1/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/13
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/14
|
0.00%
0/13
|
7.7%
1/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14
|
0.00%
0/13
|
15.4%
2/13
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
2/14
|
0.00%
0/13
|
0.00%
0/13
|
0.00%
0/12
|
|
Vascular disorders
Hot flush
|
7.1%
1/14
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/12
|
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