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Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01519284
First received: January 23, 2012
Last updated: July 22, 2015
Last verified: July 2015

January 23, 2012
July 22, 2015
November 2009
February 2010   (final data collection date for primary outcome measure)
Cmax - Maximum Plasma Concentration of Levodopa [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
To investigate the effect of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg; once-daily) on the levodopa pharmacokinetics, in comparison to placebo and entacapone (200 mg; thrice-daily).
Complete list of historical versions of study NCT01519284 on ClinicalTrials.gov Archive Site
  • Tmax - Time to Reach Maximum Plasma Concentration of Levodopa [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.
  • AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
  • AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.
  • pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To investigate the effect of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg; once-daily) on the 3-O-methyldopa (3-OMD) pharmacokinetics, in comparison to placebo and entacapone (200 mg; thrice-daily)
  • pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To investigate the effect of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg; once-daily) on the carbidopa pharmacokinetics, in comparison to placebo and entacapone (200 mg; thrice-daily);
  • erythrocyte soluble catechol-O-methyltransferase (S-COMT) activity [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To investigate the effect of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg; once-daily) on erythrocyte soluble catechol-O-methyltransferase (S-COMT) activity, in comparison with placebo and entacapone 200 mg (thrice-daily), in healthy subjects
  • pharmacokinetics [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To investigate the pharmacokinetics of BIA 9-1067 following repeated dosing (5 mg, 15 mg and 30 mg; once-daily) in healthy subjects
  • tolerability and safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To investigate the tolerability and safety of repeated dosing of BIA 9-1067 (5 mg, 15 mg and 30 mg; once-daily), in comparison with placebo and entacapone (200 mg; thrice-daily), in healthy subjects.
Not Provided
Not Provided
 
Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: BIA 9-1067 5 mg
    BIA 9-1067 OPC, Opicapone 5 mg
    Other Name: OPC, Opicapone
  • Drug: Entacapone
    Entacapone 200 mg
  • Drug: Placebo
    placebo (four times a day)
    Other Name: PLC, placebo
  • Drug: levodopa/carbidopa
    standard release levodopa/carbidopa 100/25 mg (single-dose)
  • Drug: BIA 9-1067 15 mg
    BIA 9-1067 OPC, Opicapone 15 mg
    Other Name: OPC, Opicapone
  • Drug: BIA 9-1067 30 mg
    BIA 9-1067 OPC, Opicapone 30 mg
    Other Name: OPC, Opicapone
  • Placebo Comparator: Group 1
    Placebo at all the dosing times
    Intervention: Drug: Placebo
  • Experimental: Group 2

    Day 1 to 7:

    BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

    Day 8:

    BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

    Interventions:
    • Drug: BIA 9-1067 5 mg
    • Drug: Placebo
    • Drug: levodopa/carbidopa
  • Experimental: Group 3

    Day 1 to 7:

    BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

    Day 8:

    BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

    Interventions:
    • Drug: Placebo
    • Drug: levodopa/carbidopa
    • Drug: BIA 9-1067 15 mg
  • Experimental: Group 4

    Day 1 to 7:

    BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

    Day 8:

    BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose

    Interventions:
    • Drug: Placebo
    • Drug: levodopa/carbidopa
    • Drug: BIA 9-1067 30 mg
  • Experimental: Group 5

    Day 1 to 7:

    Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

    Day 8:

    Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose

    Interventions:
    • Drug: Entacapone
    • Drug: Placebo
    • Drug: levodopa/carbidopa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
June 2011
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able and willing to give written informed consent.
  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of 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-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Clinical laboratory test results clinically acceptable at screening and admission to the treatment period.
  • Negative screen for alcohol and drugs of abuse at screening and admission to the treatment period.
  • Non-smokers or ex-smokers for at least 3 months.
  • (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).
  • (If female) She had a negative urine pregnancy test at screening and admission to the treatment period.

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.
  • Any abnormality in the coagulation tests.
  • Any abnormality in the liver function tests.
  • A history of relevant atopy or drug hypersensitivity.
  • A history or presence of narrow-angle glaucoma.
  • A suspicious undiagnosed skin lesions or a history of melanoma.
  • History of alcoholism or drug abuse.
  • Consumed more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission to the treatment period.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.
  • Had used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.
  • Had used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.
  • Had previously received BIA 9-1067.
  • Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
  • Had participated in more than 2 clinical trials within the 12 months prior to screening.
  • Had donated or received any blood or blood products within the 3 months prior to screening.
  • Vegetarians, vegans or had medical dietary restrictions.
  • Cannot communicate reliably with the investigator.
  • Unlikely to co-operate with the requirements of the study.
  • Unwilling or unable to gave written informed consent.
  • (If female) She was pregnant or breast-feeding.
  • (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
Both
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01519284
BIA-91067-114
No
Not Provided
Not Provided
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A
Bial - Portela C S.A.
July 2015

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