NCT03735680 · OUTCOME

Evaluate Pharmacokinetic Parameters: Cmax

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: μg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 6 days

What was measured

Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.

Analysis population: The PK analysis population is 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

Patients Receiving ONM-100 a Dose of 1 mg/kg

All patients in the study who received a single IV administration of ONM-100 at 1 mg/kg.

Patients Receiving ONM-100 at a Dose of 2 mg/kg

All patients in the study who received a single IV administration of ONM-100 at 2 mg/kg.

Patients Receiving ONM-100 at a Dose of 3 mg/kg

All patients in the study who received 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

Group	Source count
Patients Receiving ONM-100 a Dose of 1 mg/kg	9
Patients Receiving ONM-100 at a Dose of 2 mg/kg	3
Patients Receiving ONM-100 at a Dose of 3 mg/kg	6

Reported measurements

Source class 1

Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Patients Receiving ONM-100 a Dose of 1 mg/kg	26.5	16.0	Not reported	Not reported	Not reported
Patients Receiving ONM-100 at a Dose of 2 mg/kg	52.2	13.0	Not reported	Not reported	Not reported
Patients Receiving ONM-100 at a Dose of 3 mg/kg	79.5	30.0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.0
value
26.5
group Id
OG001
spread
13.0
value
52.2
group Id
OG002
spread
30.0
value
79.5

denoms

counts
group Id
OG000
value
9
group Id
OG001
value
3
group Id
OG002
value
6
units
Participants

description

Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.

dispersion Type

Geometric Coefficient of Variation

groups

description
All patients in the study who received a single IV administration of ONM-100 at 1 mg/kg.
id
OG000
title
Patients Receiving ONM-100 a Dose of 1 mg/kg
description
All patients in the study who received a single IV administration of ONM-100 at 2 mg/kg.
id
OG001
title
Patients Receiving ONM-100 at a Dose of 2 mg/kg
description
All patients in the study who received a single IV administration of ONM-100 at 3 mg/kg.
id
OG002
title
Patients Receiving ONM-100 at a Dose of 3 mg/kg

param Type

GEOMETRIC_MEAN

population Description

The PK analysis population is 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: Cmax

type

SECONDARY

unit Of Measure

μg/mL

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

Preserved source evidence · Not medical advice