Effect of Opicapone at Steady State on Warfarin Pharmacokinetics
|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: NCT02305030|
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Bial - Portela C S.A.
Information provided by (Responsible Party):
Bial - Portela C S.A.
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: BIA 9-1067 Drug: Warfarin||Phase 1|
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50 mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose of 25 mg warfarin.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: BIA 9-1067 / Warfarin
BIA 9-1067 capsules of 25 mg or 50 mg Warfarin capsules of 5 mg
Drug: BIA 9-1067
Other Name: OPC, Opicapone
Other Name: Uniwarfin
Primary Outcome Measures :
- R- and S-warfarin plasma concentration [ Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post-warfarin ]
Secondary Outcome Measures :
- Opicapone plasma concentration [ Time Frame: D1 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, and 8 h post-opicapone dose ]
- BIA 9-1103 (sulphate metabolite) plasma concentration [ Time Frame: D1 pre-dose and from D5 to D7 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, 8, 24, 48, 72 and 144 h post-opicapone dose. ]
No Contacts or Locations Provided