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Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

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: NCT02169466
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : November 3, 2015
Last Update Posted : November 3, 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 November 3, 2015
Last Update Posted Date November 3, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Cmax - Maximum Observed Plasma Concentration of Levodopa [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
  • AUC0-t - Area Under the Plasma Concentration-time Curve [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
  • AUC0-∞ - AUC From Time Zero to Infinity [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
  • Tmax - Time to Cmax [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: tmax - time to Cmax
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which the drug concentration was at or above the lower limit of quantification (AUC0-t), [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • AUC from time zero to infinity (AUC0-oo) [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • maximum inhibition of Catechol-O-Methyltransferase (COMT) activity (Emax) [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • time of occurrence of Emax (tEmax) [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
  • area under the effect-time curve (AUEC) [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Blood samples (6 mL) for the assay were to be taken at the following times: pre-dose, 1, 1.5, 2, 2.5, 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 Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
Official Title  ICMJE Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, 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 controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).
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 least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.
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
    Other Name: OPC, Opicapone
  • Drug: Placebo
    PLC, Placebo
    Other Name: PLC, Placebo
  • Drug: Madopar® HBS
    controlled-release levodopa 100 mg/benserazide 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Madopar® HBS
  • 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Madopar® HBS
  • 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Madopar® HBS
  • 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 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

    Interventions:
    • Drug: BIA 9-1067
    • Drug: Placebo
    • Drug: Madopar® HBS
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)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.
  • Subjects who had 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.
  • Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.
  • Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, or
  • 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.
  • Subjects who had a clinically relevant surgical history.
  • Subjects who had a clinically relevant family history.
  • Subjects who had a history of relevant atopy.
  • Subjects who had a history of relevant drug hypersensitivity.
  • Subjects who had a history of glaucoma.
  • Subjects who had a history of alcoholism or drug abuse.
  • Subjects who consumed more than 21 units of alcohol a week.
  • Subjects who had a significant infection or known inflammatory process on screening or first admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  • Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
  • Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
  • Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
  • Subjects who were vegetarians, vegans or have medical dietary restrictions.
  • Subjects who could not communicate reliably with the investigator.
  • Subjects who were unlikely to co-operate with the requirements of the study.
  • Subjects who were unwilling or unable to give written informed consent.
  • Subjects who were BIAL - Portela & Cª, SA employees.
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 Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169466
Other Study ID Numbers  ICMJE BIA-91067-109
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 October 2015

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