Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 88 of 733 for:    warfarin

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin

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: NCT02169440
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : December 22, 2015
Last Update Posted : December 22, 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 (PD)
Interventions Drug: BIA 9-1067
Drug: Warfarin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: BIA 9-1067 + Warfarin, Then Warfarin Group 2: Warfarin, Then BIA 9-1067 + Warfarin
Hide Arm/Group Description

Period 1: BIA 9-1067 + warfarin Period 2: warfarin

BIA 9-1067: BIA 9-1067 25 mg

Warfarin: Warfarin 25 mg

Period 1: warfarin Period 2: BIA 9-1067 + warfarin

BIA 9-1067: BIA 9-1067 25 mg

Warfarin: Warfarin 25 mg

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Group 1: BIA 9-1067 + Warfarin, Then Warfarin Group 2: Warfarin, Then BIA 9-1067 + Warfarin Total
Hide Arm/Group Description

Period 1: BIA 9-1067 + warfarin Period 2: warfarin

BIA 9-1067: BIA 9-1067 25 mg

Warfarin: Warfarin 25 mg

Period 1: warfarin Period 2: BIA 9-1067 + warfarin

BIA 9-1067: BIA 9-1067 25 mg

Warfarin: Warfarin 25 mg

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 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 10 participants 10 participants 20 participants
Female
5
  50.0%
5
  50.0%
10
  50.0%
Male
5
  50.0%
5
  50.0%
10
  50.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)
Hide Description Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 + Warfarin
Hide Arm/Group Description:
BIA 9-1067 25 mg + Warfarin 25 mg
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
196  (106)
2.Primary Outcome
Title Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)
Hide Description Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 + Warfarin
Hide Arm/Group Description:
BIA 9-1067 25 mg + Warfarin 25 mg
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
3.00
(1.0 to 6.0)
3.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)
Hide Description Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 + Warfarin
Hide Arm/Group Description:
BIA 9-1067 25 mg + Warfarin 25 mg
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
610  (420)
4.Primary Outcome
Title Cmax = Maximum Plasma Concentration (Warfarin Alone)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Alone
Hide Arm/Group Description:
Warfarin 25 mg
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
1940  (364)
5.Primary Outcome
Title Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Alone
Hide Arm/Group Description:
Warfarin 25 mg
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
2.50
(0.5 to 16.0)
6.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Alone
Hide Arm/Group Description:
Warfarin 25 mg
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
75098  (13792)
7.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin + BIA 9-1067
Hide Arm/Group Description:
25 mg warfarin + 25 mg BIA 9-1067
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
2003  (392)
8.Primary Outcome
Title Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin + BIA 9-1067
Hide Arm/Group Description:
25 mg warfarin + 25 mg BIA 9-1067
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
3.00
(0.5 to 8.0)
9.Primary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)
Hide Description Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067
Time Frame before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin + BIA 9-1067
Hide Arm/Group Description:
25 mg warfarin + 25 mg BIA 9-1067
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
78177  (15196)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIA 9-1067 + Warfarin Warfarin
Hide Arm/Group Description BIA 9-1067 25 mg Warfarin 25 mg Warfarin 25 mg
All-Cause Mortality
BIA 9-1067 + Warfarin Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BIA 9-1067 + Warfarin Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIA 9-1067 + Warfarin Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   6/20 (30.00%)   7/20 (35.00%) 
Eye disorders     
Blepharitis  0/20 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain upper  0/20 (0.00%)  1/20 (5.00%) 
Gingival bleeding  0/20 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Vessel puncture site haematoma  0/20 (0.00%)  1/20 (5.00%) 
Investigations     
Blood creatine phosphokinase increased  2/20 (10.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1/20 (5.00%)  0/20 (0.00%) 
Nervous system disorders     
Dizziness  1/20 (5.00%)  0/20 (0.00%) 
Headache  1/20 (5.00%)  1/20 (5.00%) 
Hypoaesthesia  1/20 (5.00%)  0/20 (0.00%) 
Presyncope  1/20 (5.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1/20 (5.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1/20 (5.00%)  0/20 (0.00%) 
Vascular disorders     
Haematoma  0/20 (0.00%)  1/20 (5.00%) 
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
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: NCT02169440     History of Changes
Other Study ID Numbers: BIA-91067-116
First Submitted: January 24, 2012
First Posted: June 23, 2014
Results First Submitted: July 22, 2015
Results First Posted: December 22, 2015
Last Update Posted: December 22, 2015