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Bioavailability and Bioequivalence Study of Two Different Sources 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116295
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects.

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

Detailed Description:

Single-center, fasted, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-periods, two-sequence, crossover study in 2 groups of subjects.

In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC approved formulation [AF] or a single 25 mg dose of OPC formulation to be submitted for approval [NF].

In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC (AF), or a single 50 mg dose of OPC (NF

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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: A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - 25 mg OPC
In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC [AF] or a single 25 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours
Drug: Opicapone (OPC)
Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).
Other Names:
  • Ongentys
  • BIA 9-1067

Experimental: Group 2 - 50 mg OPC
In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC [AF], or a single 50 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours
Drug: Opicapone (OPC)
Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).
Other Names:
  • Ongentys
  • BIA 9-1067




Primary Outcome Measures :
  1. Maximum observed drug concentration. (Cmax) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  2. Time of the maximum drug concentration (tmax) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  3. Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  4. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  5. Apparent terminal elimination rate constant - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  6. Apparent terminal elimination half-life (t1/2) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  7. Apparent total body clearance (CL/F) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  8. Apparent volume of distribution (V/F) - Period 1 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  9. Maximum observed drug concentration (Cmax) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  10. Time of the maximum drug concentration (tmax) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  11. Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  12. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  13. Apparent terminal elimination rate constant - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  14. Apparent terminal elimination half-life (t1/2) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  15. Apparent total body clearance (CL/F) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables

  16. Apparent volume of distribution (V/F) - Period 2 [ Time Frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose ]
    Pharmacokinetic variables



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:

  • Subjects signed and dated the ICF before any study-specific screening procedure.
  • Male and female subjects, between 18 and 55 years of age (inclusive).
  • BMI between 18 and 30 kg/m² inclusive.
  • Subjects have a supine blood pressure (after at least 5 minutes rest in supine position) of: systolic blood pressure ≥90 and <140 mmHg, diastolic blood pressure ≥50 and <90 mmHg and a pulse rate ≥50 and ≤90 bpm (beats per minute).
  • Subjects have no clinically relevant abnormal ECG parameters: heart rate ≥50 and ≤90 bpm, PR interval ≤ 220 milliseconds (ms), QRS duration ≤120 ms, QTcB interval ≤450 ms. No clinically relevant pathological findings in the 12-lead ECG.
  • 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 virus antibodies (HCVab) and anti-HIV 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.
  • If female, the pregnancy test at screening and at admission to each treatment period must be negative.
  • Female subjects are of non-childbearing potential (postmenopausal [no menses for at least 1 year] or surgically sterile [tubal ligation, hysterectomy or bilateral oophorectomy]). Female subjects of childbearing potential must use an acceptable method of non-hormonal method of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical investigation. Acceptable methods for this study are: intrauterine device, condom or occlusive cap (diaphragm or cervical or vault caps) with spermicide, true abstinence or vasectomized male partner, provided that he is the sole partner of that subject).
  • Able to participate, and willing to give written ICF and comply with the study restrictions.

Exclusion Criteria:

  • Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history.
  • Subjects with clinically relevant neurologic or psychiatric illness.
  • Subjects with a history of symptomatic orthostatic hypotension.
  • Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) as judged by the Principal investigator.
  • Subjects with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
  • Subjects with clinically significant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the kidney function tests especially creatinine above 1.2 x upper limit of normal (ULN) and/or liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST],) above 1.25 x ULN confirmed by two repeated measurements, when it is checked during the screening laboratory tests.
  • Subjects with a history of relevant atopy or drug hypersensitivity.
  • Subjects with a history of alcoholism and/or drug abuse.
  • 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°)].
  • Subjects with a significant infection or known inflammatory process at screening or admission to each treatment period.
  • Subjects with acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission to each treatment period.
  • Use of medicines within 2 weeks prior to the planned first drug administration that may affect the safety or other study assessments, in the investigator's opinion (excluding single use of up to 1000 mg paracetamol).
  • Use of any investigational drug or participation in any clinical trial within 30 days or 10 half-life, whatever is longer, prior to the planned first drug administration.
  • Donation or receipt of any blood or blood products within the 2 months prior to the planned first drug administration.
  • Subjects who are vegetarians, vegans or have medical dietary restrictions.
  • Subjects who cannot communicate reliably with the investigator.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Subjects who are unwilling or unable to give written informed consent.
  • If female: She is pregnant or breast-feeding.

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): NCT03116295


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03116295    
Other Study ID Numbers: BIA-91067-129
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
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