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Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone

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ClinicalTrials.gov Identifier: NCT02305316
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, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

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

Detailed Description:
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers
Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 9-1067 non-micronized - micronized
Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized
Drug: BIA 9-1067 non-micronized
Other Name: OPC, Opicapone

Drug: BIA 9-1067 micronized
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 micronized - non-micronized
Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
Drug: BIA 9-1067 non-micronized
Other Name: OPC, Opicapone

Drug: BIA 9-1067 micronized
Other Name: OPC, Opicapone




Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma Concentration [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose. ]
    Maximum observed plasma concentration of BIA 9-1067


Secondary Outcome Measures :
  1. AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose. ]
    AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067

  2. Tmax - Time of Occurrence of Cmax of BIA 9-1067 [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose. ]
    tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067

  3. AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity [ Time Frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose. ]
    AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,
  • 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 electrocardiogram (ECG),
  • Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
  • Clinical laboratory test results clinically acceptable at screening and on D-1 of each treatment period,
  • Negative screen for alcohol and drugs of abuse at screening and on D-1 of each treatment period,
  • Non-smokers or ex-smokers for at least 3 months,
  • Volunteer able to participate, and willing to give written informed consent and comply with the study restrictions,

If female:

  • Was not of childbearing potential by reason of surgery or, if of childbearing potential, uses an effective non-hormonal 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 the entire duration of the study,
  • Negative serum pregnancy test at screening and a negative urine pregnancy test on D-1 of each treatment period.

Exclusion Criteria:

  • Any 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, or had a clinically relevant surgical history,
  • Any clinically relevant abnormality in the coagulation tests,
  • Any clinically relevant abnormality in the liver function tests,
  • History of relevant atopy or drug hypersensitivity,
  • History of alcoholism and/or drug abuse,
  • Current consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)],
  • Any significant infection or known inflammatory process on screening or admission to each treatment period,
  • Any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,
  • Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion,
  • Previously received opicapone,
  • Involvement in other clinical trials of any type within 90 days prior to screening,
  • Participation in more than 2 clinical trials within the 12 months prior to screening,
  • Blood donation or received any blood transfusion or any blood products within the 3 months prior to screening,
  • Vegetarian, vegan or had medical dietary restrictions,
  • Subject not able to communicate reliably with the investigator,
  • Subjects who were unlikely to co-operate with the requirements of the study,
  • Subjects who were unwilling or unable to give written informed consent,

If female:

  • Pregnant or breast-feeding,
  • If of childbearing potential, a positive serum pregnancy test,
  • Volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02305316    
Other Study ID Numbers: BIA-91067-120
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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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