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Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02305017
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: BIA 9-1067
Drug: Paracetamol
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Period 1 OPC + Paracetamol; Period 2 OPC Period 1 OPC; Period 2 OPC+ Paracetamol
Hide Arm/Group Description

Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)

BIA 9-1067: BIA 9-1067 50 mg

Paracetamol: Paracetamol 1g

Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;

BIA 9-1067: BIA 9-1067 50 mg

Paracetamol: Paracetamol 1g

Period Title: Overall Study
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title Period 1 OPC + Paracetamol; Period 2 OPC Period 1 OPC; Period 2 OPC+ Paracetamol Total
Hide Arm/Group Description

Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)

BIA 9-1067: BIA 9-1067 50 mg

Paracetamol: Paracetamol 1g

Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;

BIA 9-1067: BIA 9-1067 50 mg

Paracetamol: Paracetamol 1g

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
7
  50.0%
14
  50.0%
Male
7
  50.0%
7
  50.0%
14
  50.0%
1.Primary Outcome
Title Cmax - Maximum Plasma Concentration
Hide Description Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration
Time Frame before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone Alone Opicapone Plus Paracetamol
Hide Arm/Group Description:
Opicapone, OPC, BIA 9-1079 alone
Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
895  (375.9) 986  (355)
2.Secondary Outcome
Title Tmax - Time of Occurrence of Cmax
Hide Description Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.
Time Frame before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone Alone Opicapone Plus Paracetamol
Hide Arm/Group Description:
Opicapone, OPC, BIA 9-1079
Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
Overall Number of Participants Analyzed 28 28
Mean (Full Range)
Unit of Measure: hours
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
3.Secondary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification
Hide Description AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration
Time Frame before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone Alone Opicapone Plus Paracetamol
Hide Arm/Group Description:
Opicapone, OPC, BIA 9-1067 50 mg
Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
2416  (884.3) 2818  (1194)
4.Secondary Outcome
Title AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.
Hide Description AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.
Time Frame before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone Alone Opicapone Plus Paracetamol
Hide Arm/Group Description:
Opicapone, OPC, BIA 9-1067 50 mg
Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
2451  (882) 2850  (1188)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Opicapone Alone Opicapone Plus Paracetamol
Hide Arm/Group Description Opicapone, OPC, BIA 9-1079 alone Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
All-Cause Mortality
Opicapone Alone Opicapone Plus Paracetamol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Opicapone Alone Opicapone Plus Paracetamol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Opicapone Alone Opicapone Plus Paracetamol
Affected / at Risk (%) Affected / at Risk (%)
Total   1/28 (3.57%)   1/28 (3.57%) 
Infections and infestations     
Nasopharyngitis  0/28 (0.00%)  1/28 (3.57%) 
Tooth abscess  1/28 (3.57%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA version 15.1
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: NCT02305017    
Other Study ID Numbers: BIA-91067-125
First Submitted: November 28, 2014
First Posted: December 2, 2014
Results First Submitted: July 22, 2015
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2015