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Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01533077
First received: January 24, 2012
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: BIA 9-1067
Drug: Sinemet® 100/25 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1

Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 2

Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 3

Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 4

Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).


Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4
STARTED   5   5   4   4 
BIA 9-1067 50 mg   5   5   4   4 
Sinemet® 100/25   4   5   4   4 
BIA 9-1067 50 mg + Sinemet® 100/25   4   4   4   4 
Sinemet® 100/25 1 h After the BIA 9-1067   5   5   4   4 
COMPLETED   4   4   4   4 
NOT COMPLETED   1   1   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1

Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 2

Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 3

Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Group 4

Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg

BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)

Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose).

Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   4   4   18 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   5   5   4   4   18 
>=65 years   0   0   0   0   0 
Gender 
[Units: Participants]
         
Female   2   2   2   2   8 
Male   3   3   2   2   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax - Maximum Observed Plasma Concentration (L-DOPA)   [ Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

2.  Primary:   Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)   [ Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

3.  Primary:   AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)   [ Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

4.  Primary:   AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)   [ Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

5.  Primary:   Cmax - Maximum Observed Plasma Concentration (3-OMD)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose ]

6.  Primary:   Tmax - Time to Occurrence of Cmax (3-OMD)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose ]

7.  Primary:   AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

8.  Primary:   AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

9.  Primary:   Cmax - Maximum Observed Plasma Concentration (Carbidopa)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

10.  Primary:   Tmax - Time to Occurrence of Cmax (Carbidopa)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

11.  Primary:   AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

12.  Primary:   AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose ]

13.  Primary:   Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

14.  Primary:   Tmax - Time to Occurrence of Cmax (BIA 9-1067)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

15.  Primary:   AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]

16.  Primary:   AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)   [ Time Frame: Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
phone: +351 229 866 100
e-mail: jose.rocha@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01533077     History of Changes
Other Study ID Numbers: BIA-91067-117
Study First Received: January 24, 2012
Results First Received: July 22, 2015
Last Updated: November 18, 2015
Health Authority: Canada: Health Canada