Trial Outcomes & Findings for Effect of Rasagiline on BIA 9-1067 Pharmacokinetics (NCT NCT01532141)
NCT ID: NCT01532141
Last Updated: 2015-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 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: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
Group 2
Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
Group 3
Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
|
Overall Study
Period 1
|
9
|
8
|
8
|
|
Overall Study
Period 2
|
8
|
8
|
8
|
|
Overall Study
Period 3
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
Baseline characteristics by cohort
| Measure |
Group 1
n=9 Participants
Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
Group 2
n=8 Participants
Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
Group 3
n=8 Participants
Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
BIA 9-1067: 50 mg BIA 9-1067 (single-dose)
Rasagiline: 1 mg rasagiline (single-dose)
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=157 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 |
BIA 9-1067 Alone
n=25 Participants
BIA 9-1067 alone.
|
BIA 9-1067 1h Before Rasagiline
n=24 Participants
BIA 9-1067 1h before Rasagiline.
|
BIA 9-1067 Concomitant Rasagiline
n=24 Participants
BIA 9-1067 concomitant rasagiline.
|
|---|---|---|---|
|
Cmax - Maximum Observed Plasma Drug Concentration
BIA 9-1067
|
647 ng/mL
Standard Deviation 261
|
703 ng/mL
Standard Deviation 207
|
640 ng/mL
Standard Deviation 224
|
|
Cmax - Maximum Observed Plasma Drug Concentration
Rasagiline
|
NA ng/mL
Standard Deviation NA
Rasagiline was not administered
|
4.260 ng/mL
Standard Deviation 1.810
|
4.299 ng/mL
Standard Deviation 1.638
|
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-dose6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers
Outcome measures
| Measure |
BIA 9-1067 Alone
n=25 Participants
BIA 9-1067 alone.
|
BIA 9-1067 1h Before Rasagiline
n=24 Participants
BIA 9-1067 1h before Rasagiline.
|
BIA 9-1067 Concomitant Rasagiline
n=24 Participants
BIA 9-1067 concomitant rasagiline.
|
|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax)
BIA 9-1067
|
3.00 hours
Interval 0.75 to 6.0
|
3.00 hours
Interval 1.0 to 6.0
|
2.50 hours
Interval 0.5 to 6.0
|
|
Time of Occurrence of Cmax (Tmax)
Rasagiline
|
NA hours
Rasagiline was not administered
|
0.5 hours
Interval 0.3 to 1.5
|
0.5 hours
Interval 0.3 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 |
BIA 9-1067 Alone
n=25 Participants
BIA 9-1067 alone.
|
BIA 9-1067 1h Before Rasagiline
n=24 Participants
BIA 9-1067 1h before Rasagiline.
|
BIA 9-1067 Concomitant Rasagiline
n=24 Participants
BIA 9-1067 concomitant rasagiline.
|
|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
BIA 9-1067
|
1966 ng.h/mL
Standard Deviation 831.6
|
2182 ng.h/mL
Standard Deviation 794.2
|
2064 ng.h/mL
Standard Deviation 827.7
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Rasagiline
|
NA ng.h/mL
Standard Deviation NA
Rasagiline was not administered
|
3277 ng.h/mL
Standard Deviation 1114
|
3370 ng.h/mL
Standard Deviation 1115
|
Adverse Events
Before Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 9-1067 Alone
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BIA 9-1067 1h Before Rasagiline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BIA 9-1067 Concomitant Rasagiline
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=25 participants at risk
Before treatment.
|
BIA 9-1067 Alone
n=25 participants at risk
BIA 9-1067 alone.
|
BIA 9-1067 1h Before Rasagiline
n=24 participants at risk
BIA 9-1067 1h before Rasagiline.
|
BIA 9-1067 Concomitant Rasagiline
n=24 participants at risk
BIA 9-1067 concomitant rasagiline.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
General disorders
Chest discomfort
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Infections and infestations
Cystitis
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Infections and infestations
Furuncle
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25
|
4.0%
1/25
|
8.3%
2/24
|
4.2%
1/24
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/24
|
4.2%
1/24
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
0.00%
0/25
|
24.0%
6/25
|
4.2%
1/24
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24
|
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