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NCT03735680 · OUTCOME

Evaluate Pharmacokinetic Parameters: Tmax

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
MEDIAN
Unit
hr
Interval / dispersion
Full Range
Time frame
6 days

What was measured

Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

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 Dose of 1 mg/kg

All patients in this arm received IV administration of ONM-100 at a dose of 1 mg/kg.

ONM-100 at a Dose of 2 mg/kg

All patients in this arm received IV administration of ONM-100 at a dose of 2 mg/kg.

ONM-100 at a Dose of 3 mg/kg

All patients in this arm received IV administration of ONM-100 at a dose of 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 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 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
ONM-100 at Dose of 1 mg/kg0.25Not reported0.221.12Not reported
ONM-100 at a Dose of 2 mg/kg0.31Not reported0.277.35Not reported
ONM-100 at a Dose of 3 mg/kg0.31Not reported0.230.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.22
        upper Limit
        1.12
        value
        0.25
      2. group Id
        OG001
        lower Limit
        0.27
        upper Limit
        7.35
        value
        0.31
      3. group Id
        OG002
        lower Limit
        0.23
        upper Limit
        0.37
        value
        0.31
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 time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
dispersion Type
Full Range
groups
  1. description
    All patients in this arm received IV administration of ONM-100 at a dose of 1 mg/kg.
    id
    OG000
    title
    ONM-100 at Dose of 1 mg/kg
  2. description
    All patients in this arm received IV administration of ONM-100 at a dose of 2 mg/kg.
    id
    OG001
    title
    ONM-100 at a Dose of 2 mg/kg
  3. description
    All patients in this arm received IV administration of ONM-100 at a dose of 3 mg/kg.
    id
    OG002
    title
    ONM-100 at a Dose of 3 mg/kg
param Type
MEDIAN
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: Tmax
type
SECONDARY
unit Of Measure
hr

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

Preserved source evidence · Not medical advice