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NCT04105010 · OUTCOME

Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8) · Source last updated 2025-04-04

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).

What was measured

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

Analysis population: PK population (all dosed patients with at least one reportable AZD4205 plasma concentrations and no important AEs or protocol deviations that may impact PK) with Intensive PK sampling on Cycle 1, Day 1

Groups in this outcome

AZD4205 Group A

Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group B

Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group C

Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group D

Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

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

Analysis denominator · Participants

GroupSource count
AZD4205 Group A27
AZD4205 Group B16
AZD4205 Group C7
AZD4205 Group D38

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
AZD4205 Group A279.829.2Not reportedNot reportedNot reported
AZD4205 Group B512.027.7Not reportedNot reportedNot reported
AZD4205 Group C258.836.9Not reportedNot reportedNot reported
AZD4205 Group D229.240.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.2
        value
        279.8
      2. group Id
        OG001
        spread
        27.7
        value
        512.0
      3. group Id
        OG002
        spread
        36.9
        value
        258.8
      4. group Id
        OG003
        spread
        40.91
        value
        229.2
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      38
    units
    Participants
description
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG000
    title
    AZD4205 Group A
  2. description
    Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG001
    title
    AZD4205 Group B
  3. description
    Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG002
    title
    AZD4205 Group C
  4. description
    Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG003
    title
    AZD4205 Group D
param Type
GEOMETRIC_MEAN
population Description
PK population (all dosed patients with at least one reportable AZD4205 plasma concentrations and no important AEs or protocol deviations that may impact PK) with Intensive PK sampling on Cycle 1, Day 1
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).
title
Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice