Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.

Detailed Description
-----------------
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Official Title
-----------------
Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: BIA 9-1067
* Drug: Rasagiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were able and willing to give written informed consent. Male or female subjects aged between 18 and 45 years, inclusive. Subjects of body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG. Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening Subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period. Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. Subjects who were non-smokers or ex-smokers for at least 3 months. (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device. (If female) She had a negative pregnancy test (β-HCG) at screening and admission to each treatment period Exclusion Criteria: Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. Subjects who had a clinically relevant surgical history. Subjects who had any significant abnormality in the coagulation tests. Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion). Subjects who had a history of relevant atopy or drug hypersensitivity. Subjects who had a history of alcoholism or drug abuse. Subjects who consumed more than 14 units of alcohol a week. Subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period. Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. Subjects who had received fluoxetine within 5 weeks of admission to the first period. Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion. Subjects who had previously received BIA 9-1067. Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening. Subjects who have donated or received any blood or blood products within the 3 months prior to screening. Subjects who were vegetarians, vegans or have medical dietary restrictions. Subjects who could not communicated reliably with the investigator. Subjects who were unlikely to co-operate with the requirements of the study. Subjects who were unwilling or unable to give written informed consent. (If female) She was pregnant or breast-feeding. (If female) She was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device) or she uses oral contraceptives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg | Drug: BIA 9-1067<br>* 50 mg BIA 9-1067 (single-dose)<br>* Other names: OPC, Opicapone;Drug: Rasagiline<br>* 1 mg rasagiline (single-dose)<br>* Other names: Azilect®;|
| Experimental: Group 2<br>Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg | Drug: BIA 9-1067<br>* 50 mg BIA 9-1067 (single-dose)<br>* Other names: OPC, Opicapone;Drug: Rasagiline<br>* 1 mg rasagiline (single-dose)<br>* Other names: Azilect®;|
| Experimental: Group 3<br>Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone | Drug: BIA 9-1067<br>* 50 mg BIA 9-1067 (single-dose)<br>* Other names: OPC, Opicapone;Drug: Rasagiline<br>* 1 mg rasagiline (single-dose)<br>* Other names: Azilect®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma Drug Concentration |  | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Occurrence of Cmax (Tmax) | 6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose | 
| AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration |  | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, BIA 9-1067