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Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

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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.

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 BIA 9-1067 25 mg
Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: Group 2 BIA 9-1067 25 mg
Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: Group 1 BIA 9-1067 50 mg
Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
Drug: BIA 9-1067
Other Name: OPC, Opicapone

Experimental: Group 2 BIA 9-1067 50 mg
Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
Drug: BIA 9-1067
Other Name: OPC, Opicapone




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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.



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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:

  • 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.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02305329    
Other Study ID Numbers: BIA-91067-121
First Posted: December 2, 2014    Key Record Dates
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents