Trial Outcomes & Findings for Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide (NCT NCT02169895)
NCT ID: NCT02169895
Last Updated: 2015-01-15
Results Overview
Cmax - Maximum observed plasma drug concentration of benserazide
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose
Results posted on
2015-01-15
Participant Flow
Participant milestones
| Measure |
Group 1
Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg
|
Group 2
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg
|
Group 3
Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg
|
Group 4
Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Every period with concomitant single oral administration of Prolopa® 100-25
Prolopa®: levodopa/benserazide 100/25 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
25 mg BIA 9-1067
|
4
|
4
|
4
|
4
|
|
Overall Study
50 mg BIA 9-1067
|
4
|
4
|
4
|
4
|
|
Overall Study
100 mg BIA 9-1067
|
4
|
4
|
4
|
2
|
|
Overall Study
Placebo
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide
Baseline characteristics by cohort
| Measure |
Group 1
n=4 Participants
Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25
|
Group 2
n=4 Participants
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitant single oral administration of Prolopa® 100-25
|
Group 3
n=4 Participants
Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
Every period with concomitant single oral administration of Prolopa® 100-25
|
Group 4
n=4 Participants
Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Every period with concomitant single oral administration of Prolopa® 100-25
|
Total
n=16 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=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-doseCmax - Maximum observed plasma drug concentration of benserazide
Outcome measures
| Measure |
BIA 9-1067 25 mg Group
n=16 Participants
BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 50 mg Group
n=16 Participants
BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 100 mg Group
n=14 Participants
BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
Placebo Group
n=15 Participants
Placebo Group.
with concomitant single oral administration of Prolopa® 100-25
|
|---|---|---|---|---|
|
Maximum Observed Plasma Drug Concentration (Cmax)
|
1.28 ng/mL
Standard Deviation 0.97
|
1.45 ng/mL
Standard Deviation 1.02
|
1.42 ng/mL
Standard Deviation 0.79
|
0.439 ng/mL
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dosetmax - time of occurrence of Cmax of benserazide
Outcome measures
| Measure |
BIA 9-1067 25 mg Group
n=16 Participants
BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 50 mg Group
n=16 Participants
BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 100 mg Group
n=14 Participants
BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
Placebo Group
n=15 Participants
Placebo Group.
with concomitant single oral administration of Prolopa® 100-25
|
|---|---|---|---|---|
|
Tmax - Time of Occurrence of Cmax
|
1.00 hours
Interval 0.5 to 3.0
|
1.00 hours
Interval 0.5 to 1.0
|
1.00 hours
Interval 0.5 to 1.0
|
1.00 hours
Interval 0.5 to 1.0
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.AUC0-t - area under the plasma concentration-time curve of benserazide.
Outcome measures
| Measure |
BIA 9-1067 25 mg Group
n=16 Participants
BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 50 mg Group
n=16 Participants
BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 100 mg Group
n=14 Participants
BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
Placebo Group
n=15 Participants
Placebo Group.
with concomitant single oral administration of Prolopa® 100-25
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve
|
1.60 ng.h/mL
Standard Deviation 1.22
|
1.81 ng.h/mL
Standard Deviation 1.21
|
1.92 ng.h/mL
Standard Deviation 1.13
|
0.414 ng.h/mL
Standard Deviation 0.310
|
Adverse Events
BIA 9-1067 25 mg Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BIA 9-1067 50 mg Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BIA 9-1067 100 mg Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 9-1067 25 mg Group
n=16 participants at risk
BIA 9-1067 25 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 50 mg Group
n=16 participants at risk
BIA 9-1067 50 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
BIA 9-1067 100 mg Group
n=14 participants at risk
BIA 9-1067 100 mg Group.
with concomitant single oral administration of Prolopa® 100-25
|
Placebo Group
n=16 participants at risk
Placebo Group.
with concomitant single oral administration of Prolopa® 100-25
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Eye disorders
Ocular hyperaemia
|
18.8%
3/16
|
6.2%
1/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16
|
6.2%
1/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16
|
12.5%
2/16
|
7.1%
1/14
|
6.2%
1/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
General disorders
Fatigue
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
6.2%
1/16
|
|
General disorders
Feeling cold
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
General disorders
Venipuncture site swelling
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/16
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/16
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Investigations
Blood glucose decreased
|
6.2%
1/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Weakness in extremity
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Nervous system disorders
Balance disorder
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
12.5%
2/16
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Nervous system disorders
Somnolence
|
18.8%
3/16
|
31.2%
5/16
|
35.7%
5/14
|
12.5%
2/16
|
|
Nervous system disorders
Tremor
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16
|
12.5%
2/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
|
0.00%
0/16
|
7.1%
1/14
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/16
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/14
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
|
Vascular disorders
Flushing
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
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