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Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT03014375
First received: January 5, 2017
Last updated: January 6, 2017
Last verified: January 2017
  Purpose

The purpose of this study is to:

To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces


Condition Intervention Phase
Hypertension Congestive Heart Failure Drug: BIA-5-453 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • urinary excretion of BIA 5-453 associated radioactivity [ Time Frame: pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose. ]
    following a single 600 mg oral dose labeled with 98 μCi of [14C]

  • faecal excretion of BIA 5-453 associated radioactivity [ Time Frame: following a single 600 mg oral dose labeled with 98 μCi of [14C] ]
    baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.

  • amount of BIA 5-453 associated radioactivity present in the expired air [ Time Frame: baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose ]
    following a single 600 mg oral dose labeled with 98 μCi of [14C]


Enrollment: 4
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etamicastat
Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules
Drug: BIA-5-453
Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).

Detailed Description:

Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and after the study, adverse events will be monitored throughout the study.

Subjects should be hospitalized the day before the administration until 264 hours thereafter.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Caucasian male subjects, 40-55 years of age.
  • Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 160 mmHg systolic, 50 95 mmHg diastolic and pulse rate: 50 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
  • Subject body mass index must be between 18 and 28 kg/m2
  • Normal 12-lead ECG
  • Ability to communicate well with the investigator and comply with the requirements of the entire study.
  • The subject has given his written informed consent to participate in the study.

Exclusion Criteria:

  • History of serious adverse reactions or hypersensitivity to any drug.
  • Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
  • History of alcohol or drug abuse in the last 5 years.
  • Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
  • Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
  • Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
  • Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
  • Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
  • Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
  • History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
  • Positive results from the HIV serology.
  • Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
  • Positive results of the drug screening.
  • Known hypersensitivity to BIA 5-453.
  • Heavy smokers, i.e., more than 10 cigarettes per day
  • Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)
  • Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03014375

Locations
Switzerland
Swiss Pharma Contract Ltd.
Allschwil, Switzerland, CH-4123
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT03014375     History of Changes
Other Study ID Numbers: BIA-5453-103
Study First Received: January 5, 2017
Last Updated: January 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2017