Bioavailability Study of BIA 5-453

NCT03090568 | Completed Phase 1

• 1 other identifier: BIA-5453-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.

Conditions

Hypertension; Congestive Heart Failure

Outcome Measures

Primary Outcomes (4)

• Cmax - the maximum plasma concentration

  pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

• Tmax - the time of occurrence of Cmax

  pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

• AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time

  pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

• AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity

  pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Study Arms (2)

BIA 5-453 Fasting

EXPERIMENTAL

BIA 5-453 200 mg in fasting conditions

Drug: BIA 5-453

BIA 5-453 Fed

EXPERIMENTAL

BIA 5-453 200 mg in fed conditions

Drug: BIA 5-453

Interventions

BIA 5-453 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

Also known as: Etamicastat

BIA 5-453 Fasting; BIA 5-453 Fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Biotrial's Human Pharmacology Unit

Rennes, F-35000, France

Location

MeSH Terms

Conditions

Hypertension; Heart Failure

Interventions

etamicastat

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 27, 2017
• Study Start: July 15, 2008
• Primary Completion: August 14, 2008
• Study Completion: August 14, 2008
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

FR (1)