Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

NCT ID: NCT02305017

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

Brief 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.

Detailed Description

Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Period 1 OPC + Paracetamol; Period 2 OPC

Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 50 mg

Paracetamol

Intervention Type: DRUG

Paracetamol 1g

Period 1 OPC; Period 2 OPC+ Paracetamol

Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 50 mg

Paracetamol

Intervention Type: DRUG

Paracetamol 1g

Interventions

BIA 9-1067

BIA 9-1067 50 mg

Intervention Type: DRUG

Paracetamol

Paracetamol 1g

Intervention Type: DRUG

Other Intervention Names

OPC, Opicapone; acetaminophen

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BIA-91067-125

Identifier Type: -

Identifier Source: org_study_id