Clinical trial NCT02305277: Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Official title: Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 85
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, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.


Eligibility criteria: Inclusion Criteria:

* A signed and dated informed consent form before any study-specific screening procedure was performed;
* Male or female subjects aged 18 to 45 years, inclusive;
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
* 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 antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (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;
* Able to participate, and willing to give written informed consent and comply with the study restrictions.
* If female:
* She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used 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 all the duration of the study;
* She had a negative serum pregnancy test at screening and a negative urine pregnancy test at 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, or had a clinically relevant surgical history;
* Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
* Had a history of relevant atopy or drug hypersensitivity;
* Had a history of alcoholism and/or drug abuse;
* Consumed more than 14 units of alcohol per week \[1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)\];
* Had a significant infection or known inflammatory process on screening or admission to each treatment period;
* Had 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 could affect the safety or other study assessments, in the Investigator's opinion;
* Had previously received opicapone;
* Had used any investigational drug or participated in any clinical trial within 90 days 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;
* Were vegetarians, vegans or had medical dietary restrictions;
* Could not communicate reliably with the Investigator;
* Were unlikely to co-operate with the requirements of the study;
* Were unwilling or unable to give written informed consent;

If female:

* She was pregnant or breast-feeding.

Primary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration
timeFrame: before OPC dosing, and ½, 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 for BIA 9-1067
timeFrame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose
measure: Tmax - Time of Occurrence of Cmax
timeFrame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose
Other outcomes:
Locations:
Study officials:
References: