Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Acetaminophen; Opicapone

Criteria

Inclusion Criteria:

• Subjects who are able and willing to give written informed consent.

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

• Subjects of body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive.

• Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.

• Subjects who have negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

• Subjects who have clinical laboratory test results clinically acceptable at screening and admission to each treatment period.

• Subjects who have a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.

• Subjects who are non-smokers or ex-smokers for at least 3 months.

• (If female) She is 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.

• (If female) She has a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.

Exclusion Criteria:

• Subjects who have 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.

• Subjects who have a clinically relevant surgical history.

• Subjects who have any clinically relevant abnormality in the coagulation tests.

• Subjects who have any clinically relevant abnormality in the liver function tests (a case-by-case decision for any abnormality must be discussed with the Sponsor before inclusion).

• Subjects who have a history of relevant atopy or drug hypersensitivity, particularly to paracetamol or any COMT inhibitor.

• Subjects who have a history of alcoholism or drug abuse.

• Subjects who consume more than 14 units of alcohol a week.

• Subjects who have a significant infection or known inflammatory process at screening or admission to each treatment period.

• Subjects who have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.

• Subjects who have received paracetamol within 2 weeks of admission to the first period.

• Subjects who have used any other medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.

• Subjects who have previously received OPC.

• Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.

• Subjects who have participated in more than 2 clinical trials within the 12 months prior to screening.

• Subjects who have donated or received any blood or blood products within the 3 months prior to screening.

• Subjects who are vegetarians, vegans or have medical dietary restrictions.

• Subjects who cannot communicate reliably with the investigator.

• Subjects who are unlikely to co-operate with the requirements of the study.

• Subjects who are unwilling or unable to give written informed consent.

• (If female) She is pregnant or breast-feeding.

• (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.