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NCT06469138 · BASELINE

Baseline characteristics

A Study to Investigate 14C-bemcentinib in Healthy Male Subjects · Source last updated 2025-01-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
groups
  1. description
    This was the only treatment arm in the study. Up to 8 participants were to receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.
    id
    BG000
    title
    Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.40
          value
          42.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.508
          value
          172.30
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    Centimetres
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.066
          value
          80.58
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.952
          value
          27.15
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
population Description
This analysis population denotes all of the participants enrolled within the baseline analysis i.e., all eligible participants enrolled onto the study who subsequently fully completed.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
groups
  1. description
    This was the only treatment arm in the study. Up to 8 participants were to receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.
    id
    BG000
    title
    Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.40
          value
          42.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.508
          value
          172.30
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    Centimetres
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.066
          value
          80.58
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.952
          value
          27.15
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
population Description
This analysis population denotes all of the participants enrolled within the baseline analysis i.e., all eligible participants enrolled onto the study who subsequently fully completed.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice