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NCT02793128 · OUTCOME

Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.

The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study · Source last updated 2020-12-22

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

Measure
NUMBER
Unit
Hours
Interval / dispersion
Not reported
Time frame
Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101

What was measured

Half-life (t½): terminal half-life The mean apparent t½ following instillation of mitomycin into the upper urinary tract (UUT) was 1.27 hours (76 minutes), which was longer than the true t½ of mitomycin following a 30 mg bolus injection (mean t½ value of approximately 17 minutes). The apparent t½ demonstrates that UGN-101 dissolved gradually, resulting in prolonged exposure of mitomycin following local instillation into the UUT.

Analysis population: PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.

Groups in this outcome

Pharmacokinetic Population

The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.

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

Analysis denominator · Participants

GroupSource count
Pharmacokinetic Population6

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pharmacokinetic Population1.27Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.27
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Half-life (t½): terminal half-life The mean apparent t½ following instillation of mitomycin into the upper urinary tract (UUT) was 1.27 hours (76 minutes), which was longer than the true t½ of mitomycin following a 30 mg bolus injection (mean t½ value of approximately 17 minutes). The apparent t½ demonstrates that UGN-101 dissolved gradually, resulting in prolonged exposure of mitomycin following local instillation into the UUT.
groups
  1. description
    The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.
    id
    OG000
    title
    Pharmacokinetic Population
param Type
NUMBER
population Description
PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
reporting Status
POSTED
time Frame
Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101
title
Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice