Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

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: NCT02071810
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : January 9, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: BIA 9-1067 Drug: Placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 9-1067 5 mg
BIA 9-1067 (OPC, Opicapone) 5 mg
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 10 mg
BIA 9-1067 (OPC, Opicapone) 10 mg
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 20 mg
BIA 9-1067 (OPC, Opicapone) 20 mg
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 30 mg
BIA 9-1067 (OPC, Opicapone) 30 mg
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: Placebo
Placebo, PLC
Drug: Placebo
Other Name: PLC, Placebo




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02071810


Locations
Layout table for location information
France
BIOTRIAL
Rueil, Malmaison, France, F-92501
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Layout table for investigator information
Principal Investigator: Dikran Mouradian, MD BIOTRIAL

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02071810    
Other Study ID Numbers: BIA-91067-102
First Posted: February 26, 2014    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: December 24, 2015
Last Verified: November 2015
Keywords provided by Bial - Portela C S.A.:
Parkinson's disease (PD)
Opicapone
Bial
BIA 9-1067
Additional relevant MeSH terms:
Layout table for MeSH terms
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