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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01519284 |
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Date of registration:
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23/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
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Scientific title:
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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 |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01519284 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Manuel Vaz-da-Silva, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BIAL - Portela & Cª S.A |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: BIA 9-1067 15 mg
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Drug: Placebo
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Drug: BIA 9-1067 30 mg
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Drug: Entacapone
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Drug: BIA 9-1067 5 mg
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Drug: levodopa/carbidopa
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Primary Outcome(s)
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Cmax - Maximum Plasma Concentration of Levodopa
[Time Frame: 8 days]
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Secondary Outcome(s)
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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]
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AUC0-8 - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
[Time Frame: 8 days]
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Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
[Time Frame: 8 days]
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Secondary ID(s)
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BIA-91067-114
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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