Clinical trial NCT02305316: Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Official title: Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

Detailed description: Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.

Eligibility criteria: Inclusion Criteria:

* A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,
* 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 electrocardiogram (ECG),
* Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
* Clinical laboratory test results clinically acceptable at screening and on D-1 of each treatment period,
* Negative screen for alcohol and drugs of abuse at screening and on D-1 of each treatment period,
* Non-smokers or ex-smokers for at least 3 months,
* Volunteer able to participate, and willing to give written informed consent and comply with the study restrictions,

If female:

* Was not of childbearing potential by reason of surgery or, if of childbearing potential, uses an effective non-hormonal 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 the entire duration of the study,
* Negative serum pregnancy test at screening and a negative urine pregnancy test on D-1 of each treatment period.

Exclusion Criteria:

* Any 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, or had a clinically relevant surgical history,
* Any clinically relevant abnormality in the coagulation tests,
* Any clinically relevant abnormality in the liver function tests,
* History of relevant atopy or drug hypersensitivity,
* History of alcoholism and/or drug abuse,
* Current consumption of more than 14 units of alcohol per week \[1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)\],
* Any significant infection or known inflammatory process on screening or admission to each treatment period,
* Any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,
* Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion,
* Previously received opicapone,
* Involvement in other clinical trials of any type within 90 days prior to screening,
* Participation in more than 2 clinical trials within the 12 months prior to screening,
* Blood donation or received any blood transfusion or any blood products within the 3 months prior to screening,
* Vegetarian, vegan or had medical dietary restrictions,
* Subject not able to communicate 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:

* Pregnant or breast-feeding,
* If of childbearing potential, a positive serum pregnancy test,
* Volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,

Primary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Secondary outcomes:
measure: AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
measure: Tmax - Time of Occurrence of Cmax of BIA 9-1067
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
measure: AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.
Other outcomes:
Locations:
Study officials:
References: