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Effect of Food on Opicapone

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ClinicalTrials.gov Identifier: NCT03116308
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Opicapone (OPC) Phase 1

Detailed Description:
Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening administration after 2 hours fast).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
Actual Study Start Date : November 21, 2014
Actual Primary Completion Date : January 28, 2015
Actual Study Completion Date : January 28, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 50 mg OPC
Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast)
Drug: Opicapone (OPC)
50 mg OPC capsules; oral route
Other Names:
  • Ongentys
  • BIA 9-1067




Primary Outcome Measures :
  1. Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone

  2. Time to occurrence of Emax (tEmax) - Day 9 (fasted state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone

  3. Area under the effect-time curve (AUEC) - Day 9 (fasted state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone

  4. Maximum observed effect on COMT activity (Emax) - Day 10 (fed state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone

  5. Time to occurrence of Emax (tEmax) - Day 10 (fed state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone

  6. Area under the effect-time curve (AUEC) - Day 10 (fed state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacodynamic parameters for opicapone


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) - Day 9 (fasted state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacokinetic parameters for opicapone

  2. Time of occurrence of Cmax (tmax) - Day 9 (fasted state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacokinetic parameters for opicapone

  3. Maximum observed plasma concentration (Cmax) - Day 10 (fed state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacokinetic parameters for opicapone

  4. Time of occurrence of Cmax (tmax) - Day 10 (fed state) [ Time Frame: Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose ]
    Pharmacokinetic parameters for opicapone



Information from the National Library of Medicine

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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:

  • Able and willing to give written informed consent and to comply with the study restrictions.
  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
  • Clinical laboratory test results clinically acceptable at screening and admission.
  • Negative screen for alcohol and drugs of abuse at screening and admission.
  • Non-smokers or ex-smokers for at least 3 months.
  • If female:
  • Not of childbearing potential by reason of surgery or, if of childbearing potential, she 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 is the sole partner of that subject) for all the duration of the study.
  • Negative serum pregnancy test at screening and a negative urine pregnancy test on admission.

Exclusion Criteria:

  • 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.
  • Clinically relevant surgical history.
  • Clinically relevant abnormality in the coagulation tests.
  • Clinically relevant abnormality in the liver function tests.
  • History of relevant atopy or drug hypersensitivity, particularly to any COMT inhibitor.
  • History of alcoholism or drug abuse.
  • Consume more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.
  • Used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.
  • Previously received OPC.
  • 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.
  • Cannot communicate reliably with the investigator.
  • Unlikely to co-operate with the requirements of the study.
  • If female:
  • Pregnant or breast-feeding.
  • Of childbearing potential and not used an approved effective contraceptive method or she uses oral contraceptives.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03116308    
Other Study ID Numbers: BIA-91067-128
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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