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A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01520727
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: BIA 9-1067 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 9-1067 10 mg
BIA 9-1067 (Opicapone, OPC) - 10 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 25 mg
BIA 9-1067 (Opicapone, OPC) - 25 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 50 mg
BIA 9-1067 (Opicapone, OPC) - 50 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 100 mg
BIA 9-1067 (Opicapone, OPC) - 100 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 200 mg
BIA 9-1067 (Opicapone, OPC) - 200 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 400 mg
BIA 9-1067 (Opicapone, OPC) - 400 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 800 mg
BIA 9-1067 (Opicapone, OPC) - 800 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Experimental: BIA 9-1067 1200 mg
BIA 9-1067 (Opicapone, OPC) - 1200 mg
Drug: BIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Other Name: Entacapone

Placebo Comparator: Placebo
Placebo (PLC): single-dose
Drug: Placebo
single-dose




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 7 weeks ]
    Safety was evaluated from the number of reported adverse events (AEs)


Secondary Outcome Measures :
  1. Cmax - BIA 9-1067 [ 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 ]
    Cmax - maximum plasma concentration

  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520727


Locations
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France
BIOTRIAL
Rennes, France, F-35000
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
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Principal Investigator: Nicolas Fauchoux, MD BIOTRIAL

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01520727    
Other Study ID Numbers: BIA-91067-101
First Posted: January 30, 2012    Key Record Dates
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
BIA 9-1067
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents