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Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites

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ClinicalTrials.gov Identifier: NCT02772614
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • maximum plasma concentration (Cmax) [ Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose ]
  • time of occurrence of Cmax (tmax) [ Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose ]
  • area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (AUC0-t) [ Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose ]
  • area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (C(t)/λz), where C(t) is the last quantifiable concentration and λz the apparent terminal rate constant (AUC0-∞) [ Time Frame: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites
Official Title  ICMJE An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration
Brief Summary

The purpose of this study is:

To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in plasma

Detailed Description

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

Each subject was to receive a single oral dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg). This was the intended radiolabelled dose without any losses; the actual administered dose was of 2.29 MBq [14C]-labelled BIA 3-202 (200 mg). Subjects were hospitalized the day before the administration until 264 hours thereafter.

Whole blood samples (2 mL) for total radioactivity analysis, plasma samples (1.5 mL) for total radioactivity analysis, and plasma samples (7 mL) for analysis of BIA 3-202 and its metabolites were collected at the following times: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose.

Urine was sampled before the drug administration (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.

Aliquots of each sample were taken for liquid scintillation counting by the investigator.

Aliquots were separated for determination of parent drug and metabolite patterns.

A baseline faeces sample was obtained during the screening or baseline period. Following dose, each faeces sample was collected in a separate container during the 264 hours post-dose period.

Vomitus (if produced) was collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: BIA 3-202 (200 mg)
200 mg powder for oral use of unlabelled BIA 3-202
Study Arms  ICMJE Experimental: Nebicapone (200 mg)

Each subject was to receive one single dose of 2.5 MBq [14C]-labelled BIA 3-202 (200 mg) together with a total of 250 mL non-carbonated water.

The study drug was given after an overnight fast of at least 10 hours after the in-house stay. During waking hours on Day 1, subjects had to have a fluid intake of at least 150 mL per hour starting 1 hour before study drug administration.

Intervention: Drug: BIA 3-202 (200 mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
4
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male subject, 40-55 years of age. Take only Caucasians.
  2. Clinically acceptable sitting blood pressure and pulse rate , i.e.: BP: 110-160 mmHg systolic, 65-95 mmHg diastolic and pulse rate: 50-100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
  3. Subject body weight must be between 50 and 95 kg and within -10% / +20% of normal for their height and frame size (according to Metropolitan Life Insurance Table, see Appendix 1&2 of the Study Protocol). Frame size will be determined using elbow breadth measurement.
  4. Normal 12-lead ECG.
  5. Ability to communicate well with the investigator and comply with the requirements of the entire study.
  6. The subject has given his written informed consent to participate in the study.

Exclusion Criteria:

  1. History of serious adverse reactions or hypersensitivity to any drug.
  2. Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
  3. History of alcohol or drug abuse in the last 5 years.
  4. Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
  5. 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.
  6. Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
  7. Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
  8. 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.
  9. Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
  10. History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
  11. Positive results from the HIV serology.
  12. Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) and CK values must be within the normal range.
  13. Positive results of the drug screening.
  14. Known hypersensitivity to BIA 3-202.
  15. Heavy smokers, i.e., more than 10 cigarettes per day.
  16. Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation).
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772614
Other Study ID Numbers  ICMJE BIA-3202-106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP