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Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa

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: NCT02169479
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE January 20, 2012
First Posted Date  ICMJE June 23, 2014
Results First Submitted Date  ICMJE January 9, 2015
Results First Posted Date  ICMJE August 17, 2015
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • Cmax - Maximum Observed Plasma Concentration of Levodopa [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
  • Tmax - Time of Occurrence of Cmax of Levodopa [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Tmax - time of occurrence of Cmax of levodopa.
  • AUC0-t - Area Under the Plasma Concentration-time Curve [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Area under the plasma concentration-time curve for levodopa
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Blood samples (6 mL) for the assay of were to be taken at the following times: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • time of occurrence of Cmax (tmax) [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Blood samples (6 mL) for the assay of were to be taken at the following times: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • area under the plasma concentration-time curve (AUC) [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose ]
    Blood samples (6 mL) for the assay of were to be taken at the following times: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa
Official Title  ICMJE Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects
Brief Summary To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)
Detailed Description Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least 14 days. On each treatment period, after completion of pre-dose assessments, BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® 100/25; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose. Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease (PD)
Intervention  ICMJE
  • Drug: BIA 9-1067
    OPC, Opicapone
  • Drug: Placebo
    PLC, Placebo
  • Drug: Sinemet® 100/25
    Immediate-release levodopa/carbidopa 100/25 mg
Study Arms  ICMJE
  • Experimental: Group 1

    Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo

    BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Sinemet® 100/25
  • Experimental: Group 2

    Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg

    BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Sinemet® 100/25
  • Experimental: Group 3

    Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg

    BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Sinemet® 100/25
  • Experimental: Group 4

    Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg

    BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Sinemet® 100/25
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer prior to participation in the study.
  2. Male volunteers.
  3. Volunteers of at least 18 years of age but not older than 45 years.
  4. Volunteers with body mass index (BMI) greater than or equal to 19 and below 30 kg/m2.
  5. Volunteers who are non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
  6. Volunteers who are healthy as determined by pre-study (at screening) medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  7. Volunteers who have clinical laboratory test results judged clinically acceptable (within the laboratory's stated normal range; if not within this range, they must be without any clinical significance) at screening and admission to first treatment period.
  8. Volunteers who have negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
  9. Volunteers who have negative screen of ethyl alcohol and drugs of abuse at screening.
  10. Due to unknown risks and potential harm to the unborn fetus, sexually active men must agree to use a medically acceptable form of contraception throughout the study.

Exclusion Criteria:

  1. Volunteers who do not conform to the above inclusion criteria, or in case of
  2. Volunteers who have a clinically relevant surgical history.
  3. Volunteers who have a clinically relevant family history.
  4. Volunteers who have a history of relevant atopy.
  5. Volunteers who have a significant infection or known inflammatory process at screening or first admission.
  6. Volunteers who have acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  7. Volunteers who are vegetarians, vegans or have medical dietary restrictions.
  8. Volunteers who cannot communicate reliably with the investigator.
  9. Volunteers who are unlikely to co-operate with the requirements of the study.
  10. Significant history of hypersensitivity to BIA 9-1067, tolcapone, entacapone, levodopa, carbidopa or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
  11. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
  12. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability.
  13. Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, lymphatic, musculoskeletal, genitourinary, endocrine, immunologic, dermatologic or connective tissue disease.
  14. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases.
  15. Presence of significant heart disease or disorder according to ECG.
  16. Presence of suspicious undiagnosed skin lesions or a history of melanoma.
  17. Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis.
  18. Presence or history of significant glaucoma.
  19. Use of prescription medications including MAO inhibitors within 28 days before day 1 of the study.
  20. Use of over-the-counter (OTC) products within 7 days before day 1 of the study.
  21. Maintenance therapy with any drug, or significant history of drug dependency (drug abuse) or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
  22. Any clinically significant illness in the previous 28 days before day 1 of this study.
  23. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study.
  24. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study.
  25. Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician.
  26. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
  27. Positive urine screening of ethyl alcohol or drugs of abuse at admission to any treatment period.
  28. Any history of tuberculosis and/or prophylaxis for tuberculosis.
  29. Positive results to HIV, HBsAg or anti-HCV tests.
  30. Participation in any previous clinical study with BIA 9-1067 within 84 days before day 1 of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169479
Other Study ID Numbers  ICMJE BIA-91067-108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP