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NCT01072175 · OUTCOME

Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib

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
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Day 15 and Day 16

What was measured

The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.

Analysis population: PK Population

Groups in this outcome

Part A: Dabrafenib 75 mg + Trametinib 2 mg

Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).

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: Dabrafenib 75 mg + Trametinib 2 mg7

Reported measurements

Day 15
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Dabrafenib 75 mg + Trametinib 2 mg9.7Not reported618Not reported
Day 16
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Dabrafenib 75 mg + Trametinib 2 mg10.2Not reported617Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        18
        value
        9.7
    title
    Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        17
        value
        10.2
    title
    Day 16
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.
dispersion Type
Full Range
groups
  1. description
    Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
    id
    OG000
    title
    Part A: Dabrafenib 75 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
PK Population
reporting Status
POSTED
time Frame
Day 15 and Day 16
title
Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib
type
SECONDARY
unit Of Measure
ng/mL

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

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