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NCT03735680 · OUTCOME

Evaluate Pharmacokinetic Parameters: CL

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
L/hr
Interval / dispersion
Geometric Coefficient of Variation
Time frame
6 days

What was measured

Evaluate Total body clearance \[CL\] 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 the 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/kg2
ONM-100 at a Dose of 2 mg/kg0
ONM-100 at a Dose of 3 mg/kg2

Reported measurements

Source class 1
Values in L/hr · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ONM-100 at a Dose of 1 mg/kg0.0532.57Not reportedNot reportedNot reported
ONM-100 at a Dose of 3 mg/kg0.05370.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.57
        value
        0.053
      2. group Id
        OG002
        spread
        70.5
        value
        0.053
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Evaluate Total body clearance \[CL\] 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
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 the 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: CL
type
SECONDARY
unit Of Measure
L/hr

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

Preserved source evidence · Not medical advice