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NCT03397706 · OUTCOME

Area Under Curve (AUC) 0-t of VRx-3996

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 VRx-3996 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. The PK Population will also be used for individual and mean figures for plasma concentrations.

Groups in this outcome

Phase 1b Dose Escalation Cohort 2a

VRx-3996: 5 mg BID valganciclovir: 450 mg BID

Phase 1b Dose Escalation Cohorts 1, 2b and 2c

VRx-3996: 10 mg QD or BID valganciclovir: 450 mg QD or BID or 900 mg QD or BID

Phase 1b Dose Escalation Cohort 3

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

Phase 2 RP2D - Capsule

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

Phase 2 RP2D - Tablet

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

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 Cohort 2a5
Phase 1b Dose Escalation Cohorts 1, 2b and 2c15
Phase 1b Dose Escalation Cohort 35
Phase 2 RP2D - Capsule30
Phase 2 RP2D - Tablet9

Reported measurements

Single-dose

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation Cohort 2a3
Phase 1b Dose Escalation Cohorts 1, 2b and 2c14
Phase 1b Dose Escalation Cohort 32
Phase 2 RP2D - Capsule26
Phase 2 RP2D - Tablet7
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 2a12867.0Not reportedNot reportedNot reported
Phase 1b Dose Escalation Cohorts 1, 2b and 2c22976.4Not reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 3340384Not reportedNot reportedNot reported
Phase 2 RP2D - Capsule417299Not reportedNot reportedNot reported
Phase 2 RP2D - Tablet587212Not reportedNot reportedNot reported
Multiple-dose

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation Cohort 2a0
Phase 1b Dose Escalation Cohorts 1, 2b and 2c0
Phase 1b Dose Escalation Cohort 30
Phase 2 RP2D - Capsule8
Phase 2 RP2D - Tablet7
Values in h*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 RP2D - Capsule638418Not reportedNot reportedNot reported
Phase 2 RP2D - Tablet474268Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.0
        value
        128
      2. group Id
        OG001
        spread
        76.4
        value
        229
      3. group Id
        OG002
        spread
        384
        value
        340
      4. group Id
        OG003
        spread
        299
        value
        417
      5. group Id
        OG004
        spread
        212
        value
        587
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        26
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Single-dose
  2. categories
    1. measurements
      1. group Id
        OG003
        spread
        418
        value
        638
      2. group Id
        OG004
        spread
        268
        value
        474
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Multiple-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      9
    units
    Participants
description
PK assessment of VRx-3996 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
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    OG000
    title
    Phase 1b Dose Escalation Cohort 2a
  2. description
    VRx-3996: 10 mg QD or BID valganciclovir: 450 mg QD or BID or 900 mg QD or BID
    id
    OG001
    title
    Phase 1b Dose Escalation Cohorts 1, 2b and 2c
  3. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG002
    title
    Phase 1b Dose Escalation Cohort 3
  4. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG003
    title
    Phase 2 RP2D - Capsule
  5. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG004
    title
    Phase 2 RP2D - Tablet
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. The PK Population will also be used for individual and mean figures for plasma concentrations.
reporting Status
POSTED
time Frame
Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1
title
Area Under Curve (AUC) 0-t of VRx-3996
type
SECONDARY
unit Of Measure
h*ng/mL

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Preserved source evidence · Not medical advice