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Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169466
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : November 3, 2015
Last Update Posted : November 3, 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: Madopar® HBS
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIA 9-1067: 25, 50, 100, Placebo BIA 9-1067: 50, 100, Placebo, 25 BIA 9-1067: 100, Placebo, 25, 50 BIA 9-1067: Placebo, 25, 50, 100
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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg

Period Title: Overall Study
Started 6 6 5 5
25 mg BIA 9-1067 6 5 5 5
50 mg BIA 9-1067 6 6 5 5
100 mg BIA 9-1067 6 6 5 5
Placebo 5 6 5 5
Completed 5 5 5 5
Not Completed 1 1 0 0
Arm/Group Title BIA 9-1067: 25, 50, 100, Placebo BIA 9-1067: 50, 100, Placebo, 25 BIA 9-1067: 100, Placebo, 25, 50 BIA 9-1067: Placebo, 25, 50, 100 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg

Total of all reporting groups
Overall Number of Baseline Participants 6 6 5 5 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 5 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
5
 100.0%
5
 100.0%
22
 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 6 participants 6 participants 5 participants 5 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
5
 100.0%
5
 100.0%
22
 100.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration of Levodopa
Hide Description Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.
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 Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
314  (110) 266  (77.5) 263  (94.9) 260  (119)
2.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve
Hide Description Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.
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 Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1084  (398) 1064  (365) 1140  (592) 933  (422)
3.Primary Outcome
Title AUC0-∞ - AUC From Time Zero to Infinity
Hide Description Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.
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 Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
BIA 9-1067 50 mg OPC Opicapone
BIA 9-1067 100 mg OPC Opicapone
Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
Overall Number of Participants Analyzed 19 20 19 19
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1190  (441) 1181  (373) 1326  (604) 1086  (380)
4.Primary Outcome
Title Tmax - Time to Cmax
Hide Description Primary pharmacokinetic parameter: tmax - time to Cmax
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.
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 20 20 20 20
Mean (Full Range)
Unit of Measure: hours
2.50
(1.0 to 4.0)
2.50
(1.0 to 4.0)
2.00
(1.0 to 6.0)
2.00
(1.0 to 4.0)
Time Frame Just before drug administration until 72 h post-dose
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   0/21 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/21 (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   2/21 (9.52%)   4/22 (18.18%)   3/22 (13.64%)   2/21 (9.52%) 
Infections and infestations         
Nasopharyngitis  0/21 (0.00%)  1/22 (4.55%)  0/22 (0.00%)  0/21 (0.00%) 
Oral herpes  0/21 (0.00%)  1/22 (4.55%)  0/22 (0.00%)  0/21 (0.00%) 
Pharyngitis  0/21 (0.00%)  1/22 (4.55%)  0/22 (0.00%)  0/21 (0.00%) 
Respiratory tract infection  1/21 (4.76%)  0/22 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1/21 (4.76%)  2/22 (9.09%)  0/22 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Headache  0/21 (0.00%)  0/22 (0.00%)  1/22 (4.55%)  1/21 (4.76%) 
Psychiatric disorders         
Depression  0/21 (0.00%)  0/22 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders         
Rhinorrhea  0/21 (0.00%)  0/22 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  0/21 (0.00%)  0/22 (0.00%)  1/22 (4.55%)  0/21 (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: clinical.trials@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02169466    
Other Study ID Numbers: BIA-91067-109
First Submitted: January 20, 2012
First Posted: June 23, 2014
Results First Submitted: January 9, 2015
Results First Posted: November 3, 2015
Last Update Posted: November 3, 2015