Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

Study Overview
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Brief Summary
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Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.

Detailed Description
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Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In Group 2 the volunteers received a single oral dose of 50 mg OPC

Official Title
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Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: BIA 9-1067


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18 to 45 years, inclusive; Body mass index (BMI) between 19 and 30 kg/m²; Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies 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; Able and willing to give written informed consent; If female: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for all the duration of the study; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period. Exclusion Criteria: 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; A clinically relevant surgical history; Any clinically relevant abnormality in the coagulation tests; Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor; A history of relevant atopy or drug hypersensitivity; A history of alcoholism or drug abuse; Consume more than 14 units of alcohol a week; A significant infection or known inflammatory process on 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; Used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion; Previously received OPC. Previous use of OPC was documented by questioning the subjects; Used any investigational drug or participated in any clinical trial within 90 days prior to screening Participated in more than 2 clinical trials within the 12 months prior to screening; Donated or received any blood or blood products within the 3 months prior to screening; Vegetarians, vegans or have medical dietary restrictions; Not able to communicate reliably with the investigator; Unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent; If female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method 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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Male

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 BIA 9-1067 25 mg<br>Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC | Drug: BIA 9-1067<br> <br> * Other names: OPC, Opicapone;|
| Experimental: Group 2 BIA 9-1067 25 mg<br>Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC | Drug: BIA 9-1067<br> <br> * Other names: OPC, Opicapone;|
| Experimental: Group 1 BIA 9-1067 50 mg<br>Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC | Drug: BIA 9-1067<br> <br> * Other names: OPC, Opicapone;|
| Experimental: Group 2 BIA 9-1067 50 mg<br>Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC | Drug: BIA 9-1067<br> <br> * Other names: OPC, Opicapone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma Concentration of 9-1067 | Cmax - maximum observed plasma concentration of 9-1067. | before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax - Time of Occurrence of Cmax of 9-1067 | tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067 | before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose | 
| AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t |  | before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose | 
| AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity | AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity. | before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose |