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NCT03735680 · OUTCOME

Evaluate Pharmacokinetic Parameters: AUC

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer · Source last updated 2023-07-07

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

Measure
GEOMETRIC_MEAN
Unit
hr x μg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
6 days

What was measured

Evaluate the Area under the time-concentration curve \[AUC\] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.

Analysis population: The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.

Groups in this outcome

ONM-100 at a Dose of 1 mg/kg

Patients receiving a single IV administration of ONM-100 at 1 mg/kg.

ONM-100 at a Dose of 2 mg/kg

Patients received a single IV administration of ONM-100 at 2 mg/kg.

ONM-100 at a Dose of 3 mg/kg

Patients receiving a single IV administration of ONM-100 at 3 mg/kg.

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

Analysis denominator · Participants

GroupSource count
ONM-100 at a Dose of 1 mg/kg9
ONM-100 at a Dose of 2 mg/kg3
ONM-100 at a Dose of 3 mg/kg6

Reported measurements

Source class 1
Values in hr x μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ONM-100 at a Dose of 1 mg/kg433127Not reportedNot reportedNot reported
ONM-100 at a Dose of 2 mg/kg150980.1Not reportedNot reportedNot reported
ONM-100 at a Dose of 3 mg/kg206738.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        127
        value
        433
      2. group Id
        OG001
        spread
        80.1
        value
        1509
      3. group Id
        OG002
        spread
        38.4
        value
        2067
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Evaluate the Area under the time-concentration curve \[AUC\] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients receiving a single IV administration of ONM-100 at 1 mg/kg.
    id
    OG000
    title
    ONM-100 at a Dose of 1 mg/kg
  2. description
    Patients received a single IV administration of ONM-100 at 2 mg/kg.
    id
    OG001
    title
    ONM-100 at a Dose of 2 mg/kg
  3. description
    Patients receiving a single IV administration of ONM-100 at 3 mg/kg.
    id
    OG002
    title
    ONM-100 at a Dose of 3 mg/kg
param Type
GEOMETRIC_MEAN
population Description
The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.
reporting Status
POSTED
time Frame
6 days
title
Evaluate Pharmacokinetic Parameters: AUC
type
SECONDARY
unit Of Measure
hr x μg/mL

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

Preserved source evidence · Not medical advice