Clinical trial NCT02305329: Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Official title: Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 56
Sex: MALE
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, 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration of 9-1067
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Secondary outcomes:
measure: Tmax - Time of Occurrence of Cmax of 9-1067
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
measure: AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
measure: AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
timeFrame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Other outcomes:
Locations:
Study officials:
References: