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Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa

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ClinicalTrials.gov Identifier: NCT02169479
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 17, 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: Sinemet® 100/25
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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg

Period Title: Overall Study
Started 4 4 4 4
25 mg BIA 9-1067 4 3 4 4
50 mg BIA 9-1067 4 4 4 4
100 mg BIA 9-1067 3 4 4 4
Placebo 3 3 4 4
Completed 3 3 4 4
Not Completed 1 1 0 0
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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 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

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg

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 Cmax - Maximum Observed Plasma Concentration of Levodopa
Hide Description Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
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 BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 25 mg OPC Opicapone
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC
Overall Number of Participants Analyzed 15 16 15 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
896  (300.2) 1088  (315.5) 1014  (267.7) 889  (307.6)
2.Primary Outcome
Title Tmax - Time of Occurrence of Cmax of Levodopa
Hide Description Tmax - time of occurrence of Cmax of levodopa.
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 BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 25 mg OPC Opicapone
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC
Overall Number of Participants Analyzed 15 16 15 14
Median (Full Range)
Unit of Measure: hours
0.5
(0.5 to 2.0)
0.5
(0.5 to 3.0)
0.5
(0.5 to 1.5)
0.5
(0.5 to 1.5)
3.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve
Hide Description Area under the plasma concentration-time curve for levodopa
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 BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 25 mg OPC Opicapone
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC
Overall Number of Participants Analyzed 15 16 15 14
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1629  (394.2) 1727  (405.8) 1853  (361.3) 1629  (438.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Hide Arm/Group Description BIA 9-1067 25 mg OPC Opicapone BIA 9-1067 50 mg OPC Opicapone BIA 9-1067 100 mg OPC Opicapone Placebo, PLC
All-Cause Mortality
BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%)   0/15 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/15 (46.67%)   9/16 (56.25%)   5/15 (33.33%)   4/14 (28.57%) 
Eye disorders         
Conjunctivitis  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/14 (7.14%) 
Photofobia  0/15 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders         
Constipation  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/14 (7.14%) 
Diarrhoea  1/15 (6.67%)  1/16 (6.25%)  0/15 (0.00%)  1/14 (7.14%) 
Heartburn  0/15 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Nausea  2/15 (13.33%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Vomiting  1/15 (6.67%)  0/16 (0.00%)  0/15 (0.00%)  0/14 (0.00%) 
General disorders         
Fatigue  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Vessel puncture site haematoma  1/15 (6.67%)  0/16 (0.00%)  0/15 (0.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications         
Skin laceration  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  0/15 (0.00%)  0/16 (0.00%)  2/15 (13.33%)  0/14 (0.00%) 
Blood phosphorus decreased  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Electrocardiogram QT prolonged  0/15 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Gamma-glutamyltransferase increased  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1/15 (6.67%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders         
Groin pain  0/15 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Muscle spasms  1/15 (6.67%)  0/16 (0.00%)  0/15 (0.00%)  0/14 (0.00%) 
Musculoskeletal chest pain  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Nervous system disorders         
Disturbance in attention  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Dizziness  0/15 (0.00%)  3/16 (18.75%)  0/15 (0.00%)  0/14 (0.00%) 
Headache  2/15 (13.33%)  2/16 (12.50%)  0/15 (0.00%)  0/14 (0.00%) 
Somnolence  3/15 (20.00%)  2/16 (12.50%)  1/15 (6.67%)  1/14 (7.14%) 
Psychiatric disorders         
Nervousness  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Nightmare  0/15 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders         
Hematuria  0/15 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  0/15 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/14 (0.00%) 
Vascular disorders         
Pallor  1/15 (6.67%)  0/16 (0.00%)  0/15 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA 12.0
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: NCT02169479    
Other Study ID Numbers: BIA-91067-108
First Submitted: January 20, 2012
First Posted: June 23, 2014
Results First Submitted: January 9, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015