Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

Study Overview
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Brief Summary
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The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.

Detailed Description
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Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers

Official Title
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Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers

Conditions
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Parkinson Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 19 and 30 kg/m2, inclusive. Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG. Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening. Clinical laboratory test results clinically acceptable at screening and admission to each treatment period. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. 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 urine pregnancy test at screening and admission to each treatment period. Exclusion Criteria: 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. Clinically relevant surgical history. Any abnormality in the coagulation tests. Any abnormality in the liver function tests. A history of relevant atopy or drug hypersensitivity. History of alcoholism or drug abuse. Consumed more than 14 units of alcohol a week. Significant infection or known inflammatory process at screening or admission to each treatment period. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion. Had previously received BIA 9-1067. Had used any investigational drug or participated in any clinical trial within 6 months prior to screening. Had participated in more than 2 clinical trials within the 12 months prior to screening. Had donated or received any blood or blood products within the 3 months prior to screening. Vegetarians, vegans or had medical dietary restrictions. Cannot communicate reliably with the investigator. Unlikely to co-operate with the requirements of the study. Unwilling or unable to gave written informed consent. Employees at BIAL - Portela & Cª, S.A. (If female) She was pregnant or breast-feeding. (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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: BIA 9-1067 + repaglinide Period 2: Repaglinide | Drug: BIA 9-1067<br>* 25 mg BIA 9-1067 (single-dose)<br>* Other names: OPC, Opicapone;Drug: Repaglinide<br>* 0.5 mg repaglinide (single-dose)<br>* Other names: Novonorm®;|
| Experimental: Group 2<br>Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide | Drug: BIA 9-1067<br>* 25 mg BIA 9-1067 (single-dose)<br>* Other names: OPC, Opicapone;Drug: Repaglinide<br>* 0.5 mg repaglinide (single-dose)<br>* Other names: Novonorm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma 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 |
| --- | --- | --- |
| Tmax - Time of Occurrence of Cmax |  | 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. | 
| AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity |  | 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
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, BIA 9-1067