Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

Parkinson's Disease Clinical Trial

Official title:

Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305017
• Other study ID #: BIA-91067-125
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2014
• Last updated: October 16, 2015
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: October 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• BIA 9-1067
BIA 9-1067 50 mg
• Paracetamol
Paracetamol 1g

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Plasma Concentration	Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration	before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose	No
Secondary	Tmax - Time of Occurrence of Cmax	Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.	before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose	No
Secondary	AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification	AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration	before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose	No
Secondary	AUC0-8 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.	AUC0-8 - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.	before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose	No