Effect of Food on Opicapone
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Opicapone (OPC)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
50 mg OPC
Arm Description
Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast)
Outcomes
Primary Outcome Measures
Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Time to occurrence of Emax (tEmax) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Area under the effect-time curve (AUEC) - Day 9 (fasted state)
Pharmacodynamic parameters for opicapone
Maximum observed effect on COMT activity (Emax) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Time to occurrence of Emax (tEmax) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Area under the effect-time curve (AUEC) - Day 10 (fed state)
Pharmacodynamic parameters for opicapone
Secondary Outcome Measures
Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)
Pharmacokinetic parameters for opicapone
Time of occurrence of Cmax (tmax) - Day 9 (fasted state)
Pharmacokinetic parameters for opicapone
Maximum observed plasma concentration (Cmax) - Day 10 (fed state)
Pharmacokinetic parameters for opicapone
Time of occurrence of Cmax (tmax) - Day 10 (fed state)
Pharmacokinetic parameters for opicapone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03116308
Brief Title
Effect of Food on Opicapone
Official Title
Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 21, 2014 (Actual)
Primary Completion Date
January 28, 2015 (Actual)
Study Completion Date
January 28, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.
Detailed Description
Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening administration after 2 hours fast).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg OPC
Arm Type
Experimental
Arm Description
Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast)
Intervention Type
Drug
Intervention Name(s)
Opicapone (OPC)
Other Intervention Name(s)
Ongentys, BIA 9-1067
Intervention Description
50 mg OPC capsules; oral route
Primary Outcome Measure Information:
Title
Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Time to occurrence of Emax (tEmax) - Day 9 (fasted state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Area under the effect-time curve (AUEC) - Day 9 (fasted state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Maximum observed effect on COMT activity (Emax) - Day 10 (fed state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Time to occurrence of Emax (tEmax) - Day 10 (fed state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Area under the effect-time curve (AUEC) - Day 10 (fed state)
Description
Pharmacodynamic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)
Description
Pharmacokinetic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Time of occurrence of Cmax (tmax) - Day 9 (fasted state)
Description
Pharmacokinetic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Maximum observed plasma concentration (Cmax) - Day 10 (fed state)
Description
Pharmacokinetic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Title
Time of occurrence of Cmax (tmax) - Day 10 (fed state)
Description
Pharmacokinetic parameters for opicapone
Time Frame
Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-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:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Food on Opicapone
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