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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
  Purpose

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.


Condition Intervention Phase
Parkinson Disease
 Drug: BIA 9-1067
Drug: entacapone
Drug: Placebo
Drug: levodopa/carbidopa
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 82
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIA 9-1067 Drug: BIA 9-1067
5 mg, 15 mg, and 30 mg of BIA 9-1067 (once-daily)
Active Comparator: entacapone Drug: entacapone
200 mg entacapone (thrice-daily)
Placebo Comparator: placebo Drug: Placebo
placebo (four times a day)
Active Comparator: levodopa/carbidopa Drug: levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)

Detailed Description:

Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519284

Locations
Portugal
Bial - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01519284     History of Changes
Other Study ID Numbers: BIA-91067-114
Study First Received: January 23, 2012
Last Updated: January 23, 2012
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Parkinson Disease
BIA 9-1067

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Entacapone
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013