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Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

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ClinicalTrials.gov Identifier: NCT02071823
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.

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

Detailed Description:
Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Crossover Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules in Healthy Male Volunteers Following Administration of a 50 mg Dose / Fasted and Fed States
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A Fed/Fasted

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fed Washout Period (7days) Period 2: Fasted

Drug: BIA 9-1067
A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
Other Name: Opicapone, OPC

Experimental: Group B Fasted/Fed

A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fasted Washout Period (7days) Period 2: Fed

Drug: BIA 9-1067
A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
Other Name: Opicapone, OPC




Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma Concentration [ Time Frame: Day 1 ]
    Cmax - Maximum observed plasma concentration of BIA 9-1067

  2. AUCt - Cumulative Area Under the Plasma Concentration Time Curve [ Time Frame: Day 1 ]
    AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067

  3. Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) [ Time Frame: Day 1 ]
    Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067



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:

  • Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
  • Male volunteer
  • Volunteer aged of at least 18 years but not older than 45 years
  • Volunteer with a body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
  • Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
  • Healthy according to the medical history, laboratory results and physical examination
  • Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study
  • The informed consent form must be signed by all volunteers, prior to their participation in the study.

Exclusion Criteria:

  • Volunteers presenting any of the following will not be included in the study:Significant history of hypersensitivity to any catechol-structured drugs (e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamide) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
  • History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
  • Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic, dermatologic or connective tissue disease
  • Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
  • Presence of significant heart disease or disorder according to ECG
  • Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis
  • Pheochromocytoma due to the increased risk of hypertensive crisis
  • Use of MAO inhibitors within 14 days of day 1 of the study
  • Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the previous 28 days before day 1 of this study
  • Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study
  • Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
  • Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
  • Positive urine screening of drugs of abuse
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive results to HIV, HBsAg or anti-HCV tests

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): NCT02071823


Locations
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Canada, Quebec
Algorithme Pharma Inc.
Mount-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
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Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02071823    
Other Study ID Numbers: BIA-91067-104
First Posted: February 26, 2014    Key Record Dates
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Opicapone,
Parkinson,
Bial,
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