Clinical trial NCT03090568: Bioavailability Study of BIA 5-453
Official title: Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Congestive Heart Failure
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cmax - the maximum plasma concentration
timeFrame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: Tmax - the time of occurrence of Cmax
timeFrame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
timeFrame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
measure: AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
timeFrame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotrial's Human Pharmacology Unit
Study officials:
References: