A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
BIA 9-1067
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring BIA 9-1067
Eligibility Criteria
Inclusion Criteria:
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Exclusion Criteria:
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
- History of any clinically important drug allergy.
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- Donation of blood (i.e. 450 mL) within 60 days before study day 1
Sites / Locations
- BIOTRIAL
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BIA 9-1067 10 mg
BIA 9-1067 25 mg
BIA 9-1067 50 mg
BIA 9-1067 100 mg
BIA 9-1067 200 mg
BIA 9-1067 400 mg
BIA 9-1067 800 mg
BIA 9-1067 1200 mg
Placebo
Arm Description
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067 (Opicapone, OPC) - 1200 mg
Placebo (PLC): single-dose
Outcomes
Primary Outcome Measures
Adverse Events (AEs)
Safety was evaluated from the number of reported adverse events (AEs)
Secondary Outcome Measures
Cmax - BIA 9-1067
Cmax - maximum plasma concentration
Time to Cmax (Tmax)
Full Information
NCT ID
NCT01520727
First Posted
January 18, 2012
Last Updated
December 29, 2014
Sponsor
Bial - Portela C S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01520727
Brief Title
A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
Official Title
A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2009 (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
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.
Detailed Description
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
BIA 9-1067
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIA 9-1067 10 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 10 mg
Arm Title
BIA 9-1067 25 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 25 mg
Arm Title
BIA 9-1067 50 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 50 mg
Arm Title
BIA 9-1067 100 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 100 mg
Arm Title
BIA 9-1067 200 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 200 mg
Arm Title
BIA 9-1067 400 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 400 mg
Arm Title
BIA 9-1067 800 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 800 mg
Arm Title
BIA 9-1067 1200 mg
Arm Type
Experimental
Arm Description
BIA 9-1067 (Opicapone, OPC) - 1200 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (PLC): single-dose
Intervention Type
Drug
Intervention Name(s)
BIA 9-1067
Other Intervention Name(s)
Entacapone
Intervention Description
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single-dose
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Safety was evaluated from the number of reported adverse events (AEs)
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Cmax - BIA 9-1067
Description
Cmax - maximum plasma concentration
Time Frame
pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Title
Time to Cmax (Tmax)
Time Frame
pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A signed and dated informed consent form before any study-specific screening procedure was performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Exclusion Criteria:
Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
History of drug abuse within 1 year before study day 1.
History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (i.e. 450 mL) within 60 days before study day 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Fauchoux, MD
Organizational Affiliation
Biotrial
Official's Role
Principal Investigator
Facility Information:
Facility Name
BIOTRIAL
City
Rennes
ZIP/Postal Code
F-35000
Country
France
12. IPD Sharing Statement
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A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
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