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Trial record 6 of 18 for:    "Basal Ganglia Disease" | "Benserazide"

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide

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ClinicalTrials.gov Identifier: NCT02169895
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : January 15, 2015
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease (PD)
Interventions Drug: BIA 9-1067
Drug: Placebo
Drug: Prolopa®
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 4 4 4 4
25 mg BIA 9-1067 4 4 4 4
50 mg BIA 9-1067 4 4 4 4
100 mg BIA 9-1067 4 4 4 2
Placebo 4 4 4 4
Completed 4 4 4 2
Not Completed 0 0 0 2
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
16
 100.0%
1.Primary Outcome
Title Maximum Observed Plasma Drug Concentration (Cmax)
Hide Description Cmax - Maximum observed plasma drug concentration of benserazide
Time Frame pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Hide Arm/Group Description:

BIA 9-1067 25 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 50 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 100 mg Group.

with concomitant single oral administration of Prolopa® 100-25

Placebo Group.

with concomitant single oral administration of Prolopa® 100-25

Overall Number of Participants Analyzed 16 16 14 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.28  (0.97) 1.45  (1.02) 1.42  (0.79) 0.439  (0.24)
2.Primary Outcome
Title Tmax - Time of Occurrence of Cmax
Hide Description tmax - time of occurrence of Cmax of benserazide
Time Frame pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Hide Arm/Group Description:

BIA 9-1067 25 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 50 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 100 mg Group.

with concomitant single oral administration of Prolopa® 100-25

Placebo Group.

with concomitant single oral administration of Prolopa® 100-25

Overall Number of Participants Analyzed 16 16 14 15
Median (Full Range)
Unit of Measure: hours
1.00
(0.5 to 3.0)
1.00
(0.5 to 1.0)
1.00
(0.5 to 1.0)
1.00
(0.5 to 1.0)
3.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve
Hide Description AUC0-t - area under the plasma concentration-time curve of benserazide.
Time Frame pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Hide Arm/Group Description:

BIA 9-1067 25 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 50 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 100 mg Group.

with concomitant single oral administration of Prolopa® 100-25

Placebo Group.

with concomitant single oral administration of Prolopa® 100-25

Overall Number of Participants Analyzed 16 16 14 15
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1.60  (1.22) 1.81  (1.21) 1.92  (1.13) 0.414  (0.310)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Hide Arm/Group Description

BIA 9-1067 25 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 50 mg Group.

with concomitant single oral administration of Prolopa® 100-25

BIA 9-1067 100 mg Group.

with concomitant single oral administration of Prolopa® 100-25

Placebo Group.

with concomitant single oral administration of Prolopa® 100-25

All-Cause Mortality
BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/14 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIA 9-1067 25 mg Group BIA 9-1067 50 mg Group BIA 9-1067 100 mg Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   10/16 (62.50%)   9/14 (64.29%)   6/16 (37.50%) 
Cardiac disorders         
Arrhythmia supraventricular  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Atrioventricular block first degree  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Ear and labyrinth disorders         
Vertigo  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Eye disorders         
Ocular hyperaemia  3/16 (18.75%)  1/16 (6.25%)  0/14 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders         
Abdominal distension  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Abdominal pain  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Constipation  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  1/16 (6.25%) 
Dry mouth  0/16 (0.00%)  1/16 (6.25%)  1/14 (7.14%)  0/16 (0.00%) 
Nausea  2/16 (12.50%)  2/16 (12.50%)  1/14 (7.14%)  1/16 (6.25%) 
Vomiting  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
General disorders         
Fatigue  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  1/16 (6.25%) 
Feeling cold  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Venipuncture site swelling  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Vessel puncture site reaction  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%) 
Infections and infestations         
Upper respiratory tract infection  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications         
Skin laceration  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%) 
Thermal burn  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%) 
Investigations         
Aspartate aminotransferase increased  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Blood creatine phosphokinase increased  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Blood glucose decreased  1/16 (6.25%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Back pain  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Muscular weakness  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Weakness in extremity  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Nervous system disorders         
Balance disorder  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Dizziness  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Dysgeusia  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Headache  2/16 (12.50%)  0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%) 
Somnolence  3/16 (18.75%)  5/16 (31.25%)  5/14 (35.71%)  2/16 (12.50%) 
Tremor  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Psychiatric disorders         
Anxiety  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Insomnia  1/16 (6.25%)  2/16 (12.50%)  0/14 (0.00%)  0/16 (0.00%) 
Renal and urinary disorders         
Proteinuria  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  1/16 (6.25%) 
Dry throat  0/16 (0.00%)  0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%) 
Epistaxis  1/16 (6.25%)  0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%) 
Nasal dryness  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Pharyngolaryngeal pain  0/16 (0.00%)  0/16 (0.00%)  0/14 (0.00%)  1/16 (6.25%) 
Rhinorrhoea  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
Vascular disorders         
Flushing  0/16 (0.00%)  1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02169895     History of Changes
Other Study ID Numbers: BIA-91067-107
First Submitted: January 20, 2012
First Posted: June 23, 2014
Results First Submitted: January 8, 2015
Results First Posted: January 15, 2015
Last Update Posted: January 15, 2015