A Single Oral Ascending Dose Study of BIA 9-1067 in Healt... | NCT01520727

NCT01520727

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIA 9-1067 10 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 10 mg	Drug: BIA 9-1067
BIA 9-1067 25 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 25 mg	Drug: BIA 9-1067
BIA 9-1067 50 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 50 mg	Drug: BIA 9-1067
BIA 9-1067 100 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 100 mg	Drug: BIA 9-1067
BIA 9-1067 200 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 200 mg	Drug: BIA 9-1067
BIA 9-1067 400 mg	Experimental	BIA 9-1067 (Opicapone, OPC) - 400 mg	Drug: BIA 9-1067

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIA 9-1067	Drug	single ascending doses in up to 8 sequential groups of 8 healthy young male subjects	BIA 9-1067 10 mg BIA 9-1067 100 mg BIA 9-1067 1200 mg

Outcomes Module

Measure	Description	Time Frame
Adverse Events (AEs)	Safety was evaluated from the number of reported adverse events (AEs)	7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cmax - BIA 9-1067	Cmax - maximum plasma concentration	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
Time to Cmax (Tmax)

Eligibility Module

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

Name	Affiliation	Role
Nicolas Fauchoux, MD	Biotrial	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
BIOTRIAL		Rennes		F-35000	France

Arm/Group Information

ID	Title	Description
FG000	BIA 9-1067 10 mg	BIA 9-1067 (Opicapone, OPC) - 10 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG001	BIA 9-1067 25 mg	BIA 9-1067 (Opicapone, OPC) - 25 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG002	BIA 9-1067 50 mg	BIA 9-1067 (Opicapone, OPC) - 50 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG003	BIA 9-1067 100 mg	BIA 9-1067 (Opicapone, OPC) - 100 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG004	BIA 9-1067 200 mg	BIA 9-1067 (Opicapone, OPC) - 200 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG005	BIA 9-1067 400 mg	BIA 9-1067 (Opicapone, OPC) - 400 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG006	BIA 9-1067 800 mg	BIA 9-1067 (Opicapone, OPC) - 800 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG007	BIA 9-1067 1200 mg	BIA 9-1067 (Opicapone, OPC) - 1200 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
FG008	Placebo	Placebo (PLC): single-dose Placebo: single-dose

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	BIA 9-1067 10 mg	BIA 9-1067 (Opicapone, OPC) - 10 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
BG001	BIA 9-1067 25 mg

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adverse Events (AEs)

Safety was evaluated from the number of reported adverse events (AEs)

Posted

Number

Number of Adverse Events

7 weeks

ID	Title	Description
OG000	BIA 9-1067 10 mg	BIA 9-1067 (Opicapone, OPC) - 10 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
OG001	BIA 9-1067 25 mg	BIA 9-1067 (Opicapone, OPC) - 25 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
OG002	BIA 9-1067 50 mg

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BIA 9-1067 10 mg	BIA 9-1067 (Opicapone, OPC) - 10 mg BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
C549349	opicapone
C071192	entacapone