Trial Outcomes & Findings for Effect of BIA 9-1067 on Rasagiline Pharmacokinetics (NCT NCT01532128)
NCT ID: NCT01532128
Last Updated: 2015-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Results posted on
2015-08-20
Participant Flow
Participant milestones
| Measure |
Group 1
Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
Group 2
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
Group 3
Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Baseline characteristics by cohort
| Measure |
Group 1
n=8 Participants
Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
Group 2
n=8 Participants
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
Group 3
n=8 Participants
Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
rasagiline: 1 mg rasagiline (single-dose)
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
|
Total
n=24 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 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
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-doseOutcome measures
| Measure |
Rasagiline Alone
n=24 Participants
Rasagiline alone.
|
Rasagiline 1 h After BIA 9-1067
n=24 Participants
Rasagiline 1 h after BIA 9-1067.
|
Rasagiline Concomitant BIA 9-1067
n=24 Participants
Rasagiline concomitant BIA 9-1067.
|
|---|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
BIA 9-1067
|
NA ng/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
672 ng/mL
Standard Deviation 226
|
643 ng/mL
Standard Deviation 232
|
|
Cmax - Maximum Observed Plasma Concentration
Rasagiline
|
6152 ng/mL
Standard Deviation 2245
|
6.058 ng/mL
Standard Deviation 2.399
|
6.078 ng/mL
Standard Deviation 2.255
|
SECONDARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-doseOutcome measures
| Measure |
Rasagiline Alone
n=24 Participants
Rasagiline alone.
|
Rasagiline 1 h After BIA 9-1067
n=24 Participants
Rasagiline 1 h after BIA 9-1067.
|
Rasagiline Concomitant BIA 9-1067
n=24 Participants
Rasagiline concomitant BIA 9-1067.
|
|---|---|---|---|
|
Tmax - Time of Occurrence of Cmax
BIA 9-1067
|
NA hours
BIA 9-1067 was not administered
|
2.00 hours
Interval 1.0 to 4.0
|
2.50 hours
Interval 0.75 to 4.0
|
|
Tmax - Time of Occurrence of Cmax
Rasagiline
|
0.50 hours
Interval 0.25 to 1.5
|
0.50 hours
Interval 0.25 to 1.5
|
0.50 hours
Interval 0.25 to 1.5
|
SECONDARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-doseOutcome measures
| Measure |
Rasagiline Alone
n=24 Participants
Rasagiline alone.
|
Rasagiline 1 h After BIA 9-1067
n=24 Participants
Rasagiline 1 h after BIA 9-1067.
|
Rasagiline Concomitant BIA 9-1067
n=24 Participants
Rasagiline concomitant BIA 9-1067.
|
|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
BIA 9-1067
|
NA ng.h/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
2133 ng.h/mL
Standard Deviation 964.1
|
1980 ng.h/mL
Standard Deviation 861.1
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Rasagiline
|
4.323 ng.h/mL
Standard Deviation 0.9727
|
4.431 ng.h/mL
Standard Deviation 1.010
|
4.391 ng.h/mL
Standard Deviation 0.8782
|
Adverse Events
Before Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Rasagiline Alone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Rasagiline 1 h After BIA 9-1067
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Rasagiline Concomitant BIA 9-1067
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 |
Before Treatment
n=24 participants at risk
|
Rasagiline Alone
n=24 participants at risk
|
Rasagiline 1 h After BIA 9-1067
n=24 participants at risk
|
Rasagiline Concomitant BIA 9-1067
n=24 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24
|
|
General disorders
Influenza like illness
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
1/24
|
12.5%
3/24
|
4.2%
1/24
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
0.00%
0/24
|
8.3%
2/24
|
4.2%
1/24
|
0.00%
0/24
|
|
Nervous system disorders
Sciatica
|
0.00%
0/24
|
4.2%
1/24
|
4.2%
1/24
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/24
|
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