Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
rasagiline
BIA 9-1067
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, BIA 9-1067
Eligibility Criteria
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.
- Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion.
- Subjects who had previously received BIA 9-1067.
- Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
- Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
- Subjects who were vegetarians, vegans or have medical dietary restrictions.
- Subjects who could not communicated reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give 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 (double-barrier, intra-uterine device) or she uses oral contraceptives.
Sites / Locations
- BIOTRIAL
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
Outcomes
Primary Outcome Measures
Cmax - Maximum Observed Plasma Concentration
Secondary Outcome Measures
Tmax - Time of Occurrence of Cmax
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01532128
Brief Title
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Official Title
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, BIA 9-1067
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
Intervention Type
Drug
Intervention Name(s)
rasagiline
Intervention Description
1 mg rasagiline (single-dose)
Intervention Type
Drug
Intervention Name(s)
BIA 9-1067
Intervention Description
50 mg BIA 9-1067 (single-dose)
Primary Outcome Measure Information:
Title
Cmax - Maximum Observed Plasma Concentration
Time Frame
pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Secondary Outcome Measure Information:
Title
Tmax - Time of Occurrence of Cmax
Time Frame
pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
Title
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Time Frame
pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion.
Subjects who had previously received BIA 9-1067.
Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
Subjects who were vegetarians, vegans or have medical dietary restrictions.
Subjects who could not communicated reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give 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 (double-barrier, intra-uterine device) or she uses oral contraceptives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatric Astruc, MD
Organizational Affiliation
Biotrial - Human Pharmacology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
BIOTRIAL
City
Rennes
ZIP/Postal Code
F-35000
Country
France
12. IPD Sharing Statement
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Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
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