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NCT01072175 · OUTCOME

Part C: Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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

Measure
MEAN
Unit
Liters (L)
Interval / dispersion
95% Confidence Interval
Time frame
Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

What was measured

Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.

Analysis population: PK Population

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Trametinib

Participants received Trametinib 1 mg or 2 mg tablets QD.

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 C: Dabrafenib 150 mg53
Part C: Trametinib109

Reported measurements

Source class 1
Values in Liters (L) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg80.8Not reported73.987.7Not reported
Part C: Trametinib184Not reported158210Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.9
        upper Limit
        87.7
        value
        80.8
      2. group Id
        OG001
        lower Limit
        158
        upper Limit
        210
        value
        184
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      109
    units
    Participants
description
Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received Trametinib 1 mg or 2 mg tablets QD.
    id
    OG001
    title
    Part C: Trametinib
param Type
MEAN
population Description
PK Population
reporting Status
POSTED
time Frame
Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
title
Part C: Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib
type
SECONDARY
unit Of Measure
Liters (L)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice