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

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ClinicalTrials.gov Identifier: NCT02169453
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : January 21, 2015
Last Update Posted : January 21, 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® CR 100/25
Enrollment 12
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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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

Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg

Period Title: Overall Study
Started 3 3 3 3
25 mg BIA 9-1067 3 3 3 3
50 mg BIA 9-1067 3 3 2 3
100 mg BIA 9-1067 3 3 3 3
Placebo 3 3 3 3
Completed 3 3 2 3
Not Completed 0 0 1 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-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

Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.

BIA 9-1067: OPC, Opicapone

Placebo: PLC, Placebo

Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg

Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
12
 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 3 participants 3 participants 3 participants 3 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
12
 100.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration
Hide Description Cmax - Maximum observed plasma concentration of 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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
716  (201.9) 673  (269.9) 570  (136.2) 554  (220.5)
2.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
Hide Description AUC0-t - Area under the plasma concentration-time curve to last measurable time point 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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1886  (396.1) 1997  (389.4) 2059  (372.7) 1575  (521.3)
3.Primary Outcome
Title AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Hide Description AUC0-∞ - Area under the plasma concentration-time curve extrapolated 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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
1986  (395.2) 2144  (437.4) 2215  (381.0) 1677  (541.7)
4.Primary Outcome
Title Emax - Maximum Inhibition of COMT Activity
Hide Description Emax - Maximum inhibition of Catechol-O-Methyltransferase (COMT) activity
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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: pmol/mg Hb/h
16.5  (10.8) 7.44  (7.42) 3.16  (4.97) 39.3  (16.0)
5.Primary Outcome
Title tEmax - Time of Occurrence of Emax
Hide Description [Not Specified]
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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: hours
4.92  (2.71) 3.59  (1.95) 2.33  (0.985) 7.17  (8.95)
6.Primary Outcome
Title AUEC0-24 - Area Under the Effect-time Curve From t=0h to t=24h
Hide Description [Not Specified]
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
[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 12 11 12 12
Mean (Standard Deviation)
Unit of Measure: pmol/mg Hb/h.h
621  (300) 427  (214) 363  (201) 1144  (445)
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   0/12 (0.00%)   0/11 (0.00%)   0/12 (0.00%)   0/12 (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   6/12 (50.00%)   4/11 (36.36%)   4/12 (33.33%)   5/12 (41.67%) 
Cardiac disorders         
Atrioventricular block first degree  0/12 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/12 (0.00%) 
Sinus arrhythmia  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders         
Foreign body sensation in eyes  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Vision blurred  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders         
Abdominal pain  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Diarrhoea  2/12 (16.67%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Dry mouth  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Flatulence  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nausea  1/12 (8.33%)  0/11 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
General disorders         
Application site erythema  0/12 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/12 (0.00%) 
Fatigue  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  2/12 (16.67%) 
Feeling hot  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Gait disturbance  0/12 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Influenza  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Electrocardiogram PR interval  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Trismus  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Neck pain  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders         
Dizziness  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Dysgeusia  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Headache  2/12 (16.67%)  0/11 (0.00%)  1/12 (8.33%)  3/12 (25.00%) 
Hypoaesthesia  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Somnolence  2/12 (16.67%)  2/11 (18.18%)  0/12 (0.00%)  3/12 (25.00%) 
Tremor  0/12 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Impatience  1/12 (8.33%)  1/11 (9.09%)  0/12 (0.00%)  1/12 (8.33%) 
Insomnia  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nightmare  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders         
Terminal dribbling  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Epistaxis  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nasal congestion  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Vascular disorders         
Hot flush  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (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: NCT02169453    
Other Study ID Numbers: BIA-91067-110
First Submitted: January 20, 2012
First Posted: June 23, 2014
Results First Submitted: January 12, 2015
Results First Posted: January 21, 2015
Last Update Posted: January 21, 2015