Bioavailability Study of BIA 5-453

NCT ID: NCT03090568

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-15
• Study Completion Date: 2008-08-14

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.

Conditions

Hypertension; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIA 5-453 Fasting

BIA 5-453 200 mg in fasting conditions

Group Type: EXPERIMENTAL

BIA 5-453

Intervention Type: DRUG

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

BIA 5-453 Fed

BIA 5-453 200 mg in fed conditions

Group Type: EXPERIMENTAL

BIA 5-453

Intervention Type: DRUG

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

Interventions

BIA 5-453

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

Intervention Type: DRUG

Other Intervention Names

Etamicastat

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biotrial's Human Pharmacology Unit

Rennes, , France

Countries

France

Other Identifiers

BIA-5453-104

Identifier Type: -

Identifier Source: org_study_id