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NCT02603172 · FLOW

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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.

groups
  1. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 milligram (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
    FG000
    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 milligram (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, once daily (QD) for 7 days.
    id
    FG001
    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
    FG002
    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, once daily (QD) for 7 days.
    id
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Part C: GSK3039294
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A (Approximately 16 Weeks)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part B (Approximately 7 Weeks)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part C (Approximately 13 Weeks)
pre Assignment Details
This was 3 parts study, participants received GSK3039294: single ascending dose in Part A; repeated dose in Part B; repeat dose in systemic amyloidosis in Part C. Participants in Part A also participated in Part B of the study.
recruitment Details
Participants took part in the study at one investigative site in the United Kingdom from 12-May-2016 to 10-May-2017. 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
groups
  1. description
    In Part A Cohort 1, participants received a single dose of GSK3039294 (dose level 1) 200 milligram (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
    FG000
    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 milligram (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, once daily (QD) for 7 days.
    id
    FG001
    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
    FG002
    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, once daily (QD) for 7 days.
    id
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Part C: GSK3039294
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A (Approximately 16 Weeks)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part B (Approximately 7 Weeks)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part C (Approximately 13 Weeks)
pre Assignment Details
This was 3 parts study, participants received GSK3039294: single ascending dose in Part A; repeated dose in Part B; repeat dose in systemic amyloidosis in Part C. Participants in Part A also participated in Part B of the study.
recruitment Details
Participants took part in the study at one investigative site in the United Kingdom from 12-May-2016 to 10-May-2017. 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