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Relative Bioavailability and Bioequivalence of Opicapone

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820037
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting conditions in healthy volunteers

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Ongentys Drug: BIA 9-1067 (test) Phase 1

Detailed Description:

This will be a Phase I, open label, randomized, partial-replicate, three-period, three-sequence crossover study to investigate the relative bioavailability and bioequivalence of 2 API sources of OPC (BIA 9-1067 [Test] and Ongentys® [Reference]) in healthy adult subjects.

Subjects will be randomized in a 3-period, 3-sequence crossover design; each subject will receive 2 single oral 50 mg doses of the Reference API source of OPC, and a single 50 mg dose of the Test API source of OPC under fasting conditions.

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be confined to the CRU until discharge on Day 3. There will be a washout period of at least 14 days between each dose. A follow-up visit will be performed 7 to 14 days after dosing in the last treatment period or early discontinuation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OPC, Ongentys
Single oral doses of 50 mg opicapone, administered using the reference (Ongentys ®) active pharmaceutical ingredient (API) source
Drug: Ongentys
single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

Experimental: BIA 9-1067
Single oral doses of 50 mg opicapone, administered using the test (BIA 9-1067)
Drug: BIA 9-1067 (test)
single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions




Primary Outcome Measures :
  1. area under the plasma concentration‑time curve from time zero to infinity (AUC0 ∞) [ Time Frame: Day 1 up to day 14 ]
    PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.

  2. area under the plasma concentration‑time curve from time zero to the last observable concentration at time t (AUC0 t) [ Time Frame: Day 1 up to day 14 ]
    PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.

  3. maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 up to day 14 ]
    PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females, between 18 and 55 years of age, inclusive.
  2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
  3. Healthy subjects as determined by no clinically significant findings from medical history, physical examination, complete neurological examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check in as assessed by the Investigator (or designee).
  4. Females will not be pregnant (i.e. the the pregnancy test at screening and at admission to each treatment period must be negative), or lactating, and females of childbearing potential and males will agree to use contraception.
  5. Able to comprehend and willing to sign and date an Informed Consent Form (ICF) before any study-specific screening procedure is performed, and to abide by the study restrictions.

Exclusion Criteria:

  1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, lymphatic, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, connective tissue diseases or disorders, musculoskeletal, psychiatric disorder, or have a clinically relevant surgical history as determined by the Investigator (or designee).
  2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  3. History of febrile illness within 10 days prior to the each dose of study drug, or subjects with evidence of active infection
  4. Acute gastrointestinal symptoms (eg nausea, vomiting, diarrhoea, heartburn) as determined by the Investigator (or designee).
  5. Significantly impaired hepatic function, defined as any of the following (confirmed by repeat):

    1. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN)
    2. Total bilirubin (TBL) > 2 x ULN
  6. Significant personal or family history of haemostatic disorders
  7. History of galactose intolerance (eg the Lapp lactase deficiency or glucose-galactose malabsorption)
  8. Symptomatic orthostatic hypotension (drop of > 20 mmHg in systolic blood pressure and/or > 10 mmHg in diastolic blood pressure) when moving from supine to standing position, together with other symptoms, e.g., dizziness.
  9. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
  10. History of alcoholism or drug/chemical abuse within 2 years prior to Check in to the first treatment period.
  11. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
  12. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check in to each treatment period.
  13. Positive hepatitis panel and/or positive human immunodeficiency virus test
  14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to first dose of study drug.
  15. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in of the first treatment period, unless deemed acceptable by the Investigator (or designee).
  16. Use or intend to use any prescription medications/products within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
  17. Use or intend to use slow release medications/products considered to still be active within 14 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
  18. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
  19. Use of tobacco or nicotine containing products within 3 months prior to Check in, or positive cotinine at Screening or Check-in.
  20. Receipt of blood products within 2 months prior to Check in.
  21. Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  22. Subjects who are vegetarians, vegans or have medical dietary restrictions
  23. Poor peripheral venous access.
  24. Have previously completed or withdrawn from this study or any other study investigating opicapone, and have previously received the investigational product.
  25. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820037


Contacts
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Contact: João Ferreira, MSc +351 220732669 joao.ferreira@bial.com
Contact: Andre Garrido, BA, MA, MFA +351 220732669 andre.garrido@bial.com

Locations
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United Kingdom
Covance Clinical Research
Leeds, United Kingdom, LS2 9LH
Contact: João Ferreira, MSc    +351 220732669    joao.ferreira@bial.com   
Contact: Andre Garrido, BA, MA, MFA    +351 220732669    andre.garrido@bial.com   
Sponsors and Collaborators
Bial - Portela C S.A.
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03820037    
Other Study ID Numbers: BIA-91067-132
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
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