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NCT02603172 · OUTCOME

Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1

What was measured

PCI ranges for the clinical chemistry parameters were as follows : albumin (low: \<0.86 gram \[g\] per liter \[L\]), calcium (low: \<0.91 millimole \[mmol\]/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total carbon dioxide (CO2) (low: \<0.86 mmol/L and high: \>1.14 mmol/L).

Analysis population: Safety population.

Groups in this outcome

Part A: GSK3039294 200 mg

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 in cohort 1.

Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: GSK3039294 200 mg8
Part A: GSK3039294 600 mg16
Part A: GSK3039294 1200 mg8

Reported measurements

Albumin: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Albumin: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Calcium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Calcium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Glucose: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Glucose: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Potassium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Potassium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Sodium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Sodium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Albumin: low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Albumin: high
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Calcium: low
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Calcium: high
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Glucose: low
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Glucose: high
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Potassium: low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Potassium: high
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Sodium: low
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Sodium: high
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      8
    units
    Participants
description
PCI ranges for the clinical chemistry parameters were as follows : albumin (low: \<0.86 gram \[g\] per liter \[L\]), calcium (low: \<0.91 millimole \[mmol\]/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total carbon dioxide (CO2) (low: \<0.86 mmol/L and high: \>1.14 mmol/L).
groups
  1. description
    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 in cohort 1.
    id
    OG000
    title
    Part A: GSK3039294 200 mg
  2. description
    Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
    id
    OG001
    title
    Part A: GSK3039294 600 mg
  3. description
    Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
    id
    OG002
    title
    Part A: GSK3039294 1200 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population.
reporting Status
POSTED
time Frame
Day 1
title
Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice