Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIA 9-1067
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Period 1 OPC + Paracetamol; Period 2 OPC
Period 1 OPC; Period 2 OPC+ Paracetamol
Arm Description
Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.
AUC0-∞ - 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.
Full Information
NCT ID
NCT02305017
First Posted
November 28, 2014
Last Updated
October 16, 2015
Sponsor
Bial - Portela C S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02305017
Brief Title
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Official Title
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1 OPC + Paracetamol; Period 2 OPC
Arm Type
Experimental
Arm Description
Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
Arm Title
Period 1 OPC; Period 2 OPC+ Paracetamol
Arm Type
Experimental
Arm Description
Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
Intervention Type
Drug
Intervention Name(s)
BIA 9-1067
Other Intervention Name(s)
OPC, Opicapone
Intervention Description
BIA 9-1067 50 mg
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
acetaminophen
Intervention Description
Paracetamol 1g
Primary Outcome Measure Information:
Title
Cmax - Maximum Plasma Concentration
Description
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
Time Frame
before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Secondary Outcome Measure Information:
Title
Tmax - Time of Occurrence of Cmax
Description
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.
Time Frame
before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Title
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
Description
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
Time Frame
before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
Title
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.
Description
AUC0-∞ - 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.
Time Frame
before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
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