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NCT03085095 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) Of Relugolix

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2

What was measured

The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.

Analysis population: A subset of Japanese participants enrolled in study were included in the PK analysis.

Groups in this outcome

Relugolix Single-Dose

Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

Relugolix Repeat-Dose

Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

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

Analysis denominator · Participants

GroupSource count
Relugolix Single-Dose7
Relugolix Repeat-Dose7

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Relugolix Single-Dose125220Not reportedNot reportedNot reported
Relugolix Repeat-Dose46.4141Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        220
        value
        125
      2. group Id
        OG001
        spread
        141
        value
        46.4
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
    id
    OG000
    title
    Relugolix Single-Dose
  2. description
    Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
    id
    OG001
    title
    Relugolix Repeat-Dose
param Type
GEOMETRIC_MEAN
population Description
A subset of Japanese participants enrolled in study were included in the PK analysis.
reporting Status
POSTED
time Frame
Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
title
Maximum Observed Plasma Concentration (Cmax) Of Relugolix
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice