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An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites

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: NCT02169427
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease (PD)
Intervention Drug: OPC
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
1.Primary Outcome
Title Cumulative Recovery of [14C]-Radioactivity
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AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine

Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards

Time Frame pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description:

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Recovery % of dose
AEurine 12.8  (1.5)
AEfaeces 67.2  (7.6)
AEair 15.9  (4.8)
AEtotal 95.9  (8.6)
2.Secondary Outcome
Title Cmax - Maximum Concentration
Hide Description BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite
Time Frame pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description:

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng [eq]/mL
14C plasma 7302  (3918)
14C blood 1920  (813)
OPC plasma 757  (321)
BIA 9-1103 plasma 118  (60.9)
3.Secondary Outcome
Title Tmax - Time to Attain Maximum Concentration
Hide Description BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite
Time Frame pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description:

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hours
14C plasma 0.51  (0.01)
14C blood 1.01  (0.01)
OPC plasma 2.43  (1.10)
BIA 9-1103 plasma 8.34  (3.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Opicapone (OPC)
Hide Arm/Group Description

100 mg OPC

OPC: The drug substance of 100 mg OPC was administered as 1 capsule.

All-Cause Mortality
Opicapone (OPC)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Opicapone (OPC)
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Opicapone (OPC)
Affected / at Risk (%)
Total   5/6 (83.33%) 
Gastrointestinal disorders   
Frequent Bowel Movements  1/6 (16.67%) 
Injury, poisoning and procedural complications   
Wound  1/6 (16.67%) 
Nervous system disorders   
Headache  1/6 (16.67%) 
Somnolence  2/6 (33.33%) 
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: NCT02169427    
Other Study ID Numbers: BIA-91067-122
First Submitted: January 24, 2012
First Posted: June 23, 2014
Results First Submitted: July 22, 2015
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015