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Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02305277
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.

Condition or disease Intervention/treatment Phase
Parkinson Drug: BIA 9-1067 (clinical micronized, CM) Drug: BIA 9-1067 (to-be-marketed, TBM) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 9-1067 5 mg Sequence 1

volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 25 mg Sequence 1

volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 50 mg Sequence 1

volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 5 mg Sequence 2

volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 25 mg Sequence 2

volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone

Experimental: BIA 9-1067 50 mg Sequence 2

volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed

Drug: BIA 9-1067 (clinical micronized, CM)
Other Name: OPC, Opicapone

Drug: BIA 9-1067 (to-be-marketed, TBM)
Other Name: OPC, Opicapone




Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma Concentration [ Time Frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose ]

Secondary Outcome Measures :
  1. AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067 [ Time Frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose ]
    Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration

  2. Tmax - Time of Occurrence of Cmax [ Time Frame: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A signed and dated informed consent form before any study-specific screening procedure was performed;
  • Male or female subjects aged 18 to 45 years, inclusive;
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
  • 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 antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) 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 to participate, and willing to give written informed consent and comply with the study restrictions.
  • If female:
  • She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used 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 all the duration of the study;
  • She had a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each treatment period.

Exclusion Criteria:

  • Subjects who had 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, or had a clinically relevant surgical history;
  • Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
  • Had a history of relevant atopy or drug hypersensitivity;
  • Had a history of alcoholism and/or drug abuse;
  • Consumed 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°)];
  • Had a significant infection or known inflammatory process on screening or admission to each treatment period;
  • Had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
  • Had used medicines within 2 weeks of admission to first period that could affect the safety or other study assessments, in the Investigator's opinion;
  • Had previously received opicapone;
  • Had used any investigational drug or participated in any clinical trial within 90 days prior to screening;
  • Had participated in more than 2 clinical trials within the 12 months prior to screening;
  • Had donated or received any blood or blood products within the 3 months prior to screening;
  • Were vegetarians, vegans or had medical dietary restrictions;
  • Could not communicate reliably with the Investigator;
  • Were unlikely to co-operate with the requirements of the study;
  • Were unwilling or unable to give written informed consent;

If female:

  • She was pregnant or breast-feeding.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02305277    
Other Study ID Numbers: BIA-91067-119
First Posted: December 2, 2014    Key Record Dates
Results First Posted: November 17, 2015
Last Update Posted: November 17, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents