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NCT02603172 · BASELINE

Baseline characteristics

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

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
      7
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      0
    9. group Id
      BG008
      value
      23
    units
    Participants
groups
  1. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2.
    id
    BG000
    title
    GSK3039294 200 mg + GSK3039294 600 mg
  2. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG001
    title
    GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD
  3. description
    In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4.
    id
    BG002
    title
    GSK3039294 600 mg +GSK3039294 1200 mg
  4. description
    In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG003
    title
    GSK3039294 600 mg +GSK3039294 1200 mg/GSK3039294 600 mg QD
  5. description
    In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG004
    title
    GSK3039294 600 mg QD
  6. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    BG005
    title
    GSK3039294 (Cohort 4a)
  7. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    BG006
    title
    GSK3039294 (Cohort 4b)
  8. description
    Participants were planned to receive repeat dose of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
    id
    BG007
    title
    Part C: GSK3039294
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.48
          value
          42.4
        2. comment
          Standard Deviation could not be calculated as only one participant was analyzed
          group Id
          BG001
          spread
          NA
          value
          26.0
        3. group Id
          BG002
          spread
          13.12
          value
          42.1
        4. comment
          Standard Deviation could not be calculated as only one participant was analyzed
          group Id
          BG003
          spread
          NA
          value
          38.0
        5. group Id
          BG004
          spread
          7.79
          value
          36.3
        6. group Id
          BG008
          spread
          9.235
          value
          38.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      CENTRAL/SOUTH ASIAN HERITAGE
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      BLACK OR AFRICAN AMERICAN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
      title
      WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4A and 4B were not recruited in Part B and Part C was not initiated.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      0
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      0
    9. group Id
      BG008
      value
      23
    units
    Participants
groups
  1. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2.
    id
    BG000
    title
    GSK3039294 200 mg + GSK3039294 600 mg
  2. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1 in Part A Cohort 2. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG001
    title
    GSK3039294 200 mg + GSK3039294 600 mg/GSK3039294 600 mg QD
  3. description
    In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4.
    id
    BG002
    title
    GSK3039294 600 mg +GSK3039294 1200 mg
  4. description
    In Part A Cohort 2, participants received GSK3039294 (dose level 3) 600 mg capsules, orally, once on Day 1, and stayed in-house until Day 4; followed by washout period from Day 5 to 14; followed by a single dose of GSK3039294 (dose level 4) 1200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4. In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG003
    title
    GSK3039294 600 mg +GSK3039294 1200 mg/GSK3039294 600 mg QD
  5. description
    In Part B Cohort 3, participants received GSK3039294 600 mg capsules, orally, under fed condition, QD for 7 days.
    id
    BG004
    title
    GSK3039294 600 mg QD
  6. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    BG005
    title
    GSK3039294 (Cohort 4a)
  7. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    BG006
    title
    GSK3039294 (Cohort 4b)
  8. description
    Participants were planned to receive repeat dose of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
    id
    BG007
    title
    Part C: GSK3039294
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.48
          value
          42.4
        2. comment
          Standard Deviation could not be calculated as only one participant was analyzed
          group Id
          BG001
          spread
          NA
          value
          26.0
        3. group Id
          BG002
          spread
          13.12
          value
          42.1
        4. comment
          Standard Deviation could not be calculated as only one participant was analyzed
          group Id
          BG003
          spread
          NA
          value
          38.0
        5. group Id
          BG004
          spread
          7.79
          value
          36.3
        6. group Id
          BG008
          spread
          9.235
          value
          38.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          23
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      CENTRAL/SOUTH ASIAN HERITAGE
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      BLACK OR AFRICAN AMERICAN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
      title
      WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4A and 4B were not recruited in Part B and Part C was not initiated.

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Preserved source evidence · Not medical advice