Back to resultsBioavailability Study of BIA 5-453
Primary Purpose
Hypertension, Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
BIA 5-453
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- aged between 18 and 45 years, inclusive.
- had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
- had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
- were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
- was able and willing to give written informed consent.
Exclusion Criteria:
- 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.
- had a clinically relevant surgical history.
- had a clinically relevant family history.
- had a history of relevant atopy or drug hypersensitivity.
- had a history of alcoholism or drug abuse.
- consumed more than 14 units of alcohol a week.
- had a significant infection or known inflammatory process at screening or admission to the first treatment period.
- had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
- used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
- used any investigational drug or participated in any clinical trial within 3 months prior to screening.
- participated in more than 2 clinical trials within the 12 months prior to screening.
- donated or received any blood or blood products within the 3 months prior to screening.
- was a vegetarian, vegan or with medical dietary restrictions.
- could not communicate reliably with the investigator.
- was unlikely to co-operate with the requirements of the study.
- was unwilling or unable to give written informed consent.
Sites / Locations
- Biotrial's Human Pharmacology Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BIA 5-453 Fasting
BIA 5-453 Fed
Arm Description
BIA 5-453 200 mg in fasting conditions
BIA 5-453 200 mg in fed conditions
Outcomes
Primary Outcome Measures
Cmax - the maximum plasma concentration
Tmax - the time of occurrence of Cmax
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03090568
Brief Title
Bioavailability Study of BIA 5-453
Official Title
Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 15, 2008 (Actual)
Primary Completion Date
August 14, 2008 (Actual)
Study Completion Date
August 14, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
Detailed Description
This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIA 5-453 Fasting
Arm Type
Experimental
Arm Description
BIA 5-453 200 mg in fasting conditions
Arm Title
BIA 5-453 Fed
Arm Type
Experimental
Arm Description
BIA 5-453 200 mg in fed conditions
Intervention Type
Drug
Intervention Name(s)
BIA 5-453
Other Intervention Name(s)
Etamicastat
Intervention Description
BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal
Primary Outcome Measure Information:
Title
Cmax - the maximum plasma concentration
Time Frame
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Title
Tmax - the time of occurrence of Cmax
Time Frame
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Title
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
Time Frame
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Title
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
Time Frame
pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged between 18 and 45 years, inclusive.
had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
was able and willing to give written informed consent.
Exclusion Criteria:
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.
had a clinically relevant surgical history.
had a clinically relevant family history.
had a history of relevant atopy or drug hypersensitivity.
had a history of alcoholism or drug abuse.
consumed more than 14 units of alcohol a week.
had a significant infection or known inflammatory process at screening or admission to the first treatment period.
had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
used any investigational drug or participated in any clinical trial within 3 months prior to screening.
participated in more than 2 clinical trials within the 12 months prior to screening.
donated or received any blood or blood products within the 3 months prior to screening.
was a vegetarian, vegan or with medical dietary restrictions.
could not communicate reliably with the investigator.
was unlikely to co-operate with the requirements of the study.
was unwilling or unable to give written informed consent.
Facility Information:
Facility Name
Biotrial's Human Pharmacology Unit
City
Rennes
ZIP/Postal Code
F-35000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bioavailability Study of BIA 5-453
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