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Effect of Rasagiline on BIA 9-1067 Pharmacokinetics | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects

NCT01532141•Bial - Portela C S.A.

Summary

The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.

Detailed Description

Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who were 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 18.0 and 30.0 kg/m2, inclusive.
•Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
•Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
•Subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
•Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
•Subjects who were 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: double barrier or intrauterine device.
•(If female) She had a negative pregnancy test (β-HCG) at screening and admission to each treatment period

Exclusion Criteria

•Subjects who had a 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.
•Subjects who had a clinically relevant surgical history.
•Subjects who had any significant abnormality in the coagulation tests.
•Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion).
•Subjects who had a history of relevant atopy or drug hypersensitivity.
•Subjects who had a history of alcoholism or drug abuse.
•Subjects who consumed more than 14 units of alcohol a week.
•Subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period.
•Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
•Subjects who had received fluoxetine within 5 weeks of admission to the first period.
+10 more criteria

Locations (1)

BIOTRIAL

Rennes, France

Key Dates

Start Date

November 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

August 1, 2010

Last Updated

August 20, 2015

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

BIA 9-1067

DRUG

Rasagiline

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients