Evidence map›Paper›PMID 42371393›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2026

A Relative Bioavailability Study of Vepdegestrant Tablets in Healthy Adult Participants.

Derek Z Yang, Kyle T Matschke, Jennifer A Winton, Kimberly C Lee, Yuanyuan Zhang, Weiwei Tan

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06347861 (A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 3-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF THE REGISTRATION TABLETS OF VEPDEGESTRANT), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06347861 phase1completednot on this map

A phase 1, randomized, open-label, 3-period, 3-treatment, 6-sequence, crossover, single-dose study in healthy adult participants to estimate the bioavailability of the registration tablets of vepdegestrant (arv-471, pf-07850327) relative to the phase 3 tablets

TypeinterventionalSponsorPfizerRan2024 to 2024Enrolled52ConditionsHealthyArmssingle dose of vepdegestrant as tablet formulation (Treatment A), single dose of vepdegestrant as tablet formulation (Treatment B), single dose of vepdegestrant as tablet formulation (Treatment C)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Derek Z YangPfizer Inc., 11202 El Camino Real, San Diego, CA, 92130, USA. Derek.Yang@pfizer.com.ORCID http://orcid.org/0000-0002-3642-7757
Kyle T MatschkePfizer, Inc., Collegeville, PA, USA.
Jennifer A WintonPfizer, Inc., Groton, CT, USA.
Kimberly C LeePfizer, Inc., Groton, CT, USA.
Yuanyuan ZhangArvinas Operations, Inc., New Haven, CT, USA.
Weiwei TanPfizer Inc., 11202 El Camino Real, San Diego, CA, 92130, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveVepdegestrant is a selective, oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader in development for the treatment of ER-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. The current study was conducted to estimate the relative bioavailability of single 200-mg doses of commercially representative vepdegestrant tablets (2 × 100-mg strength and 1 × 200-mg strength) compared with a single 200-mg dose of the pivotal phase 3 vepdegestrant tablets (2 × 100-mg strength).

methodsThis phase 1, randomized, open-label, three-period, three-treatment, six-sequence, crossover, single-dose study in healthy adults was conducted according to bioequivalence standards. Participants were to receive three vepdegestrant treatments over three treatment periods. Serial pharmacokinetic blood samples were collected up to 168 h after vepdegestrant administration in each period.

resultsFifty-two participants were enrolled and treated in the study. Following administration, vepdegestrant plasma concentration-time curves for both commercially representative tablets (test) and the pivotal phase 3 tablets (reference) were nearly superimposable. The 90% confidence intervals for the test/reference adjusted geometric means ratios of vepdegestrant area under the plasma concentration-time curve from time zero to infinity and maximum plasma concentration for both commercially representative tablets relative to the pivotal phase 3 tablets fell completely within prespecified standard bioequivalence limits (80.00-125.00%). Adverse event rates were similar across tablet formulations.

conclusionsCommercially representative vepdegestrant tablets demonstrated bioequivalence with the pivotal phase 3 vepdegestrant tablets; all tablet formulations of vepdegestrant 200 mg were well tolerated. CLINICAL

trial registrationNCT06347861; registered March 29, 2024.

Indexed as

PiperidonesAdministration, OralAdultArea Under CurveBiological AvailabilityCross-Over StudiesFemaleHealthy VolunteersHumansMaleMiddle AgedTabletsTherapeutic EquivalencyYoung AdultPiperidonesTabletsvepdegestrant

Identifiers

PMID42371393

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.