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Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

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: 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.

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE February 26, 2014
Results First Submitted Date  ICMJE December 31, 2014
Results First Posted Date  ICMJE January 9, 2015
Last Update Posted Date January 9, 2015
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2014)
  • Cmax - Maximum Observed Plasma Concentration [ Time Frame: Day 1 ]
    Cmax - Maximum observed plasma concentration of BIA 9-1067
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
  • Maximum Concentration (Cmax) [ Time Frame: Day 1 ]
    A single center, randomized, single dose, open-label, two-way, crossover comparative bioavailability study was conducted under fasting and fed conditions on twelve (12) healthy male subjects. Following a 50 mg single dose (2 x 25 mg) of BIA 9-1067 capsules the rate and extent of absorption of BIA 9-1067 were measured and compared under fasting and fed conditions
  • Area Under the Concentration-time Curve (AUCt) [ Time Frame: Day 1 ]
    A single center, randomized, single dose, open-label, two-way, crossover comparative bioavailability study was conducted under fasting and fed conditions on twelve (12) healthy male subjects. Following a 50 mg single dose (2 x 25 mg) of BIA 9-1067 capsules the rate and extent of absorption of BIA 9-1067 were measured and compared under fasting and fed conditions
  • Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) [ Time Frame: Day 1 ]
    A single center, randomized, single dose, open-label, two-way, crossover comparative bioavailability study was conducted under fasting and fed conditions on twelve (12) healthy male subjects. Following a 50 mg single dose (2 x 25 mg) of BIA 9-1067 capsules the rate and extent of absorption of BIA 9-1067 were measured and compared under fasting and fed conditions
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
Official Title  ICMJE 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
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.
Detailed Description Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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

    Intervention: Drug: BIA 9-1067
  • 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

    Intervention: Drug: BIA 9-1067
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2014)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02071823
Other Study ID Numbers  ICMJE BIA-91067-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
PRS Account Bial - Portela C S.A.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP