Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg |
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)
Other Names:
Drug: Rasagiline
1 mg rasagiline (single-dose)
Other Names:
|
Experimental: Group 2 Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg |
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)
Other Names:
Drug: Rasagiline
1 mg rasagiline (single-dose)
Other Names:
|
Experimental: Group 3 Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone |
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)
Other Names:
Drug: Rasagiline
1 mg rasagiline (single-dose)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax - Maximum Observed Plasma Drug Concentration [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 Measures
- Time of Occurrence of Cmax (Tmax) [pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose]
6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers
- AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration [pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose]
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | BIOTRIAL | Rennes | France | F-35000 |
Sponsors and Collaborators
- Bial - Portela C S.A.
Investigators
- Principal Investigator: Béatrice Astruc, MD, Biotrial - Human Pharmacology Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIA-91067-113
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) | Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) | Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) |
Period Title: Overall Study | |||
STARTED | 9 | 8 | 8 |
Period 1 | 9 | 8 | 8 |
Period 2 | 8 | 8 | 8 |
Period 3 | 8 | 8 | 8 |
COMPLETED | 8 | 8 | 8 |
NOT COMPLETED | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Group 1 | Group 2 | Group 3 | Total |
---|---|---|---|---|
Arm/Group Description | Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) | Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) | Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone BIA 9-1067: 50 mg BIA 9-1067 (single-dose) Rasagiline: 1 mg rasagiline (single-dose) | Total of all reporting groups |
Overall Participants | 9 | 8 | 8 | 25 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
9
100%
|
8
100%
|
8
100%
|
25
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
4
44.4%
|
4
50%
|
4
50%
|
12
48%
|
Male |
5
55.6%
|
4
50%
|
4
50%
|
13
52%
|
Outcome Measures
Title | Cmax - Maximum Observed Plasma Drug Concentration |
---|---|
Description | |
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline |
---|---|---|---|
Arm/Group Description | BIA 9-1067 alone. | BIA 9-1067 1h before Rasagiline. | BIA 9-1067 concomitant rasagiline. |
Measure Participants | 25 | 24 | 24 |
BIA 9-1067 |
647
(261)
|
703
(207)
|
640
(224)
|
Rasagiline |
NA
(NA)
|
4.260
(1.810)
|
4.299
(1.638)
|
Title | Time of Occurrence of Cmax (Tmax) |
---|---|
Description | 6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers |
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline |
---|---|---|---|
Arm/Group Description | BIA 9-1067 alone. | BIA 9-1067 1h before Rasagiline. | BIA 9-1067 concomitant rasagiline. |
Measure Participants | 25 | 24 | 24 |
BIA 9-1067 |
3.00
|
3.00
|
2.50
|
Rasagiline |
NA
|
0.5
|
0.5
|
Title | AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration |
---|---|
Description | |
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline |
---|---|---|---|
Arm/Group Description | BIA 9-1067 alone. | BIA 9-1067 1h before Rasagiline. | BIA 9-1067 concomitant rasagiline. |
Measure Participants | 25 | 24 | 24 |
BIA 9-1067 |
1966
(831.6)
|
2182
(794.2)
|
2064
(827.7)
|
Rasagiline |
NA
(NA)
|
3277
(1114)
|
3370
(1115)
|
Adverse Events
Time Frame | ||||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Before Treatment | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline | ||||
Arm/Group Description | Before treatment. | BIA 9-1067 alone. | BIA 9-1067 1h before Rasagiline. | BIA 9-1067 concomitant rasagiline. | ||||
All Cause Mortality |
||||||||
Before Treatment | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Before Treatment | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/25 (0%) | 0/25 (0%) | 0/24 (0%) | 0/24 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Before Treatment | BIA 9-1067 Alone | BIA 9-1067 1h Before Rasagiline | BIA 9-1067 Concomitant Rasagiline | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/25 (12%) | 11/25 (44%) | 4/24 (16.7%) | 3/24 (12.5%) | ||||
Gastrointestinal disorders | ||||||||
Constipation | 1/25 (4%) | 0/25 (0%) | 0/24 (0%) | 0/24 (0%) | ||||
Nausea | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Vomiting | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
General disorders | ||||||||
Chest discomfort | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Infections and infestations | ||||||||
Bronchitis | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Cystitis | 1/25 (4%) | 0/25 (0%) | 0/24 (0%) | 0/24 (0%) | ||||
Furuncle | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Nasopharyngitis | 1/25 (4%) | 1/25 (4%) | 2/24 (8.3%) | 1/24 (4.2%) | ||||
Tonsillitis | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Back pain | 0/25 (0%) | 0/25 (0%) | 1/24 (4.2%) | 0/24 (0%) | ||||
Neck pain | 0/25 (0%) | 0/25 (0%) | 0/24 (0%) | 1/24 (4.2%) | ||||
Nervous system disorders | ||||||||
Dizziness | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Headache | 0/25 (0%) | 6/25 (24%) | 1/24 (4.2%) | 1/24 (4.2%) | ||||
Reproductive system and breast disorders | ||||||||
Dysmenorrhoea | 0/25 (0%) | 1/25 (4%) | 0/24 (0%) | 0/24 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Pruritus | 0/25 (0%) | 0/25 (0%) | 1/24 (4.2%) | 0/24 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Head of Clinical Research |
---|---|
Organization | Bial - Portela & Cª, S.A. |
Phone | +351 229 866 100 |
jose.rocha@bial.com |
- BIA-91067-113