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Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

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: NCT02305329
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE November 28, 2014
First Posted Date  ICMJE December 2, 2014
Results First Submitted Date  ICMJE July 22, 2015
Results First Posted Date  ICMJE August 21, 2015
Last Update Posted Date August 21, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
Cmax - Maximum Observed Plasma Concentration of 9-1067 [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
Cmax - maximum observed plasma concentration of 9-1067.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
Cmax - maximum observed plasma concentration [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
Change History Complete list of historical versions of study NCT02305329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Tmax - Time of Occurrence of Cmax of 9-1067 [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
    tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067
  • AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
  • AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
    AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
  • tmax - time of occurrence of Cmax [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
  • AUC - area under the plasma concentration-time curve [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
  • AUC0-t - AUC from time zero to time at which the drug concentration was at or above the lower limit of quantification [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Official Title  ICMJE Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects
Brief Summary Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.
Detailed Description Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In Group 2 the volunteers received a single oral dose of 50 mg OPC
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 Epilepsy
Intervention  ICMJE Drug: BIA 9-1067
Other Name: OPC, Opicapone
Study Arms  ICMJE
  • Experimental: Group 1 BIA 9-1067 25 mg
    Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
    Intervention: Drug: BIA 9-1067
  • Experimental: Group 2 BIA 9-1067 25 mg
    Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
    Intervention: Drug: BIA 9-1067
  • Experimental: Group 1 BIA 9-1067 50 mg
    Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
    Intervention: Drug: BIA 9-1067
  • Experimental: Group 2 BIA 9-1067 50 mg
    Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
    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: November 28, 2014)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects aged 18 to 45 years, inclusive;
  • Body mass index (BMI) between 19 and 30 kg/m²;
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies at screening;
  • Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
  • Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
  • Non-smokers or ex-smokers for at least 3 months;
  • Able and willing to give written informed consent;
  • If female: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for all the duration of the study; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.

Exclusion Criteria:

  • A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
  • A clinically relevant surgical history;
  • Any clinically relevant abnormality in the coagulation tests;
  • Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor;
  • A history of relevant atopy or drug hypersensitivity;
  • A history of alcoholism or drug abuse;
  • Consume more than 14 units of alcohol a week;
  • A significant infection or known inflammatory process on screening or admission to each treatment period;
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
  • Used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion;
  • Previously received OPC. Previous use of OPC was documented by questioning the subjects;
  • Used any investigational drug or participated in any clinical trial within 90 days prior to screening
  • Participated in more than 2 clinical trials within the 12 months prior to screening;
  • Donated or received any blood or blood products within the 3 months prior to screening;
  • Vegetarians, vegans or have medical dietary restrictions;
  • Not able to communicate reliably with the investigator;
  • Unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent;
  • If female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method or she used oral contraceptives.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02305329
Other Study ID Numbers  ICMJE BIA-91067-121
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 Not Provided
PRS Account Bial - Portela C S.A.
Verification Date July 2015

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