Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's disease (PD), Opicapone, Bial, BIA 9-1067
Brief summary
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
Detailed description
Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.
Interventions
DRUGBIA 9-1067
DRUGPlacebo
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. A signed and dated informed consent form before any study-specific screening procedure is performed. 2. Aged between 18 and 45 years, inclusive. 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG). 4. Nonsmoker 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
1. 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. 2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1. 3. History of drug abuse within 1 year before study day 1. 4. 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 5. Have previously received BIA 9-1067. 6. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies. 7. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA \[3,4-methylenedioxy-methamphetamine; ecstasy\]). 8. History of any clinically important drug allergy. 9. Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration. 10. 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 before study day 1. 11. 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. 12. Donation of blood (ie 450 ml) within 90 days before study day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With at Least One Adverse Event | participants will be followed for the duration of hospital stay, an expected average of 6 weeks |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIA 9-1067 5 mg BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067 | 6 |
| BIA 9-1067 10 mg BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067 | 6 |
| BIA 9-1067 20 mg BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067 | 6 |
| BIA 9-1067 30 mg BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067 | 7 |
| Placebo Placebo, PLC
Placebo | 9 |
| Total | 34 |
Baseline characteristics
| Characteristic | BIA 9-1067 5 mg | BIA 9-1067 10 mg | BIA 9-1067 20 mg | BIA 9-1067 30 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 9 Participants | 34 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 9 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 6 | 1 / 6 | 1 / 6 | 2 / 7 | 0 / 9 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 1 / 9 |
Outcome results
Primary
Number of Patients With at Least One Adverse Event
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIA 9-1067 5 mg | Number of Patients With at Least One Adverse Event | 3 Number of patients |
| BIA 9-1067 10 mg | Number of Patients With at Least One Adverse Event | 1 Number of patients |
| BIA 9-1067 20 mg | Number of Patients With at Least One Adverse Event | 1 Number of patients |
| BIA 9-1067 30 mg | Number of Patients With at Least One Adverse Event | 2 Number of patients |
| Placebo | Number of Patients With at Least One Adverse Event | 1 Number of patients |