Effect of Food on Opicapone

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03116308
• Date of registration: 12/04/2017
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of Food on Opicapone
• Scientific title: Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
• Date of first enrolment: November 21, 2014
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03116308
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Key inclusion & exclusion criteria

Inclusion Criteria:

- Able and willing to give written informed consent and to comply with the study
restrictions.

- Male or female subjects aged between 18 and 45 years, inclusive.

- 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-HCV Ab and HIV-1 and HIV-2 Ab at screening.

- Clinical laboratory test results clinically acceptable at screening and admission.

- Negative screen for alcohol and drugs of abuse at screening and admission.

- Non-smokers or ex-smokers for at least 3 months.

- If female:

- Not of childbearing potential by reason of surgery or, if of childbearing potential,
she 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 is the sole partner of that subject) for
all the duration of the study.

- Negative serum pregnancy test at screening and a negative urine pregnancy test on
admission.

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.

- Clinically relevant abnormality in the coagulation tests.

- Clinically relevant abnormality in the liver function tests.

- History of relevant atopy or drug hypersensitivity, particularly to any COMT
inhibitor.

- History of alcoholism or drug abuse.

- Consume more than 14 units of alcohol a week.

- Significant infection or known inflammatory process at screening or admission.

- Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the
time of screening or admission.

- Used medicines within 2 weeks of admission that may affect the safety or other study
assessments, in the investigator's opinion.

- Previously received OPC.

- 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.

- Cannot communicate reliably with the investigator.

- Unlikely to co-operate with the requirements of the study.

- If female:

- Pregnant or breast-feeding.

- Of childbearing potential and not used an approved effective contraceptive method or
she uses oral contraceptives.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Opicapone (OPC)

Primary Outcome(s)

Maximum observed effect on COMT activity (Emax) - Day 10 (fed state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Area under the effect-time curve (AUEC) - Day 9 (fasted state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Time to occurrence of Emax (tEmax) - Day 10 (fed state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Time to occurrence of Emax (tEmax) - Day 9 (fasted state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Area under the effect-time curve (AUEC) - Day 10 (fed state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Secondary Outcome(s)

Maximum observed plasma concentration (Cmax) - Day 10 (fed state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Maximum observed plasma concentration (Cmax) - Day 9 (fasted state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Time of occurrence of Cmax (tmax) - Day 10 (fed state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Time of occurrence of Cmax (tmax) - Day 9 (fasted state) [Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose]

Secondary ID(s)

BIA-91067-128

Source(s) of Monetary Support

Please refer to primary and secondary sponsors