Status:
COMPLETED
Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Detailed Description
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01519284
Start Date
November 1 2009
End Date
June 1 2011
Last Update
August 20 2015
Active Locations (1)
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1
Bial - Portela & Cª, S.A.
S. Mamede Do Coronado, Portugal, 4745-457