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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: NA
Last verified: January 2012
History: No changes posted

January 23, 2012
January 23, 2012
November 2009
February 2010   (final data collection date for primary outcome measure)
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).
Same as current
No Changes Posted
  • 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.
Same as current
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, 15 mg, and 30 mg of BIA 9-1067 (once-daily)
  • Drug: entacapone
    200 mg entacapone (thrice-daily)
  • Drug: Placebo
    placebo (four times a day)
  • Drug: levodopa/carbidopa
    standard release levodopa/carbidopa 100/25 mg (single-dose)
  • Experimental: BIA 9-1067
    Intervention: Drug: BIA 9-1067
  • Active Comparator: entacapone
    Intervention: Drug: entacapone
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Active Comparator: levodopa/carbidopa
    Intervention: 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
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01519284
BIA-91067-114
No
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.
January 2012

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