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NCT03397706 · OUTCOME

AUC 0-t of of Valganciclovir

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies · Source last updated 2025-03-20

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

Measure
MEAN
Unit
h*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1

What was measured

PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1

Analysis population: The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations.

Groups in this outcome

Phase 1b Dose Escalation - 450 mg

valganciclovir: 450 mg QD or BID VRx-3996: 5 mg BID, 10 mg QD or BID

Phase 1b Dose Escalation - 900 mg

valganciclovir: 900mg QD or BID VRx-3996: 10 mg QD or BID, 20 mg QD on Days 1 to 4/week

Phase 2 RP2D - Capsule (VRx-3996)

valganciclovir: 900 mg QD VRx-3996: 20 mg QD on Days 1 to 4/week

Phase 2 RP2D - Tablet (VRx-3996)

valganciclovir: 900 mg QD VRx-3996: 20 mg QD on Days 1 to 4/week

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

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation - 450 mg13
Phase 1b Dose Escalation - 900 mg12
Phase 2 RP2D - Capsule (VRx-3996)30
Phase 2 RP2D - Tablet (VRx-3996)9

Reported measurements

Single-dose

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation - 450 mg12
Phase 1b Dose Escalation - 900 mg11
Phase 2 RP2D - Capsule (VRx-3996)29
Phase 2 RP2D - Tablet (VRx-3996)7
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation - 450 mg156004160Not reportedNot reportedNot reported
Phase 1b Dose Escalation - 900 mg244009300Not reportedNot reportedNot reported
Phase 2 RP2D - Capsule (VRx-3996)2520010400Not reportedNot reportedNot reported
Phase 2 RP2D - Tablet (VRx-3996)4970029100Not reportedNot reportedNot reported
Multiple-dose

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation - 450 mg0
Phase 1b Dose Escalation - 900 mg0
Phase 2 RP2D - Capsule (VRx-3996)11
Phase 2 RP2D - Tablet (VRx-3996)8
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 RP2D - Capsule (VRx-3996)2830016400Not reportedNot reportedNot reported
Phase 2 RP2D - Tablet (VRx-3996)4660018000Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4160
        value
        15600
      2. group Id
        OG001
        spread
        9300
        value
        24400
      3. group Id
        OG002
        spread
        10400
        value
        25200
      4. group Id
        OG003
        spread
        29100
        value
        49700
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    Single-dose
  2. categories
    1. measurements
      1. group Id
        OG002
        spread
        16400
        value
        28300
      2. group Id
        OG003
        spread
        18000
        value
        46600
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        8
      units
      Participants
    title
    Multiple-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      30
    4. group Id
      OG003
      value
      9
    units
    Participants
description
PK assessment of valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1D1 and C2D1
dispersion Type
Standard Deviation
groups
  1. description
    valganciclovir: 450 mg QD or BID VRx-3996: 5 mg BID, 10 mg QD or BID
    id
    OG000
    title
    Phase 1b Dose Escalation - 450 mg
  2. description
    valganciclovir: 900mg QD or BID VRx-3996: 10 mg QD or BID, 20 mg QD on Days 1 to 4/week
    id
    OG001
    title
    Phase 1b Dose Escalation - 900 mg
  3. description
    valganciclovir: 900 mg QD VRx-3996: 20 mg QD on Days 1 to 4/week
    id
    OG002
    title
    Phase 2 RP2D - Capsule (VRx-3996)
  4. description
    valganciclovir: 900 mg QD VRx-3996: 20 mg QD on Days 1 to 4/week
    id
    OG003
    title
    Phase 2 RP2D - Tablet (VRx-3996)
param Type
MEAN
population Description
The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations.
reporting Status
POSTED
time Frame
Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1
title
AUC 0-t of of Valganciclovir
type
SECONDARY
unit Of Measure
h*ng/mL

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Preserved source evidence · Not medical advice