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Bioavailability Study of BIA 5-453

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ClinicalTrials.gov Identifier: NCT03090568
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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

Condition or disease Intervention/treatment Phase
Hypertension Congestive Heart Failure Drug: BIA 5-453 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Actual Study Start Date : July 15, 2008
Actual Primary Completion Date : August 14, 2008
Actual Study Completion Date : August 14, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 5-453 Fasting
BIA 5-453 200 mg in fasting conditions
Drug: 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
Other Name: Etamicastat

Experimental: BIA 5-453 Fed
BIA 5-453 200 mg in fed conditions
Drug: 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
Other Name: Etamicastat




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090568


Locations
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France
Biotrial's Human Pharmacology Unit
Rennes, France, F-35000
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03090568     History of Changes
Other Study ID Numbers: BIA-5453-104
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases