- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305329
Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
July 22, 2015 updated by: Bial - Portela C S.A.
Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects
Single-centre, open-label, randomized, two-sequence, two-way crossover study.
The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.
Study Overview
Detailed Description
Single-centre, open-label, randomized, two-sequence, two-way crossover study.
The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.
In Group 1 the volunteers received a single oral dose of 25 mg OPC.
In Group 2 the volunteers received a single oral dose of 50 mg OPC
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male or female subjects aged 18 to 45 years, inclusive;
- Body mass index (BMI) between 19 and 30 kg/m²;
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies at screening;
- Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
- Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
- Non-smokers or ex-smokers for at least 3 months;
- Able and willing to give written informed consent;
- If female: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal 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 was the sole partner of that subject) for all the duration of the study; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.
Exclusion Criteria:
- 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;
- A clinically relevant surgical history;
- Any clinically relevant abnormality in the coagulation tests;
- Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor;
- A history of relevant atopy or drug hypersensitivity;
- A history of alcoholism or drug abuse;
- Consume more than 14 units of alcohol a week;
- A significant infection or known inflammatory process on screening or admission to each treatment period;
- Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
- Used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion;
- Previously received OPC. Previous use of OPC was documented by questioning the subjects;
- 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;
- Not able to communicate reliably with the investigator;
- Unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent;
- If female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method or she used oral contraceptives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 BIA 9-1067 25 mg
Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
|
Other Names:
|
Experimental: Group 2 BIA 9-1067 25 mg
Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
|
Other Names:
|
Experimental: Group 1 BIA 9-1067 50 mg
Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
|
Other Names:
|
Experimental: Group 2 BIA 9-1067 50 mg
Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Plasma Concentration of 9-1067
Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
Cmax - maximum observed plasma concentration of 9-1067.
|
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax - Time of Occurrence of Cmax of 9-1067
Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067
|
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
|
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.
|
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
November 28, 2014
First Submitted That Met QC Criteria
November 28, 2014
First Posted (Estimate)
December 2, 2014
Study Record Updates
Last Update Posted (Estimate)
August 21, 2015
Last Update Submitted That Met QC Criteria
July 22, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIA-91067-121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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