Evidence map›Paper›PMID 37705327›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC-92480), a novel cereblon E3 ligase modulator.

Fan Wu, Liangang Liu, Allison Gaudy, Xiaomin Wang, Leon Carayannopoulos, Michael Pourdehnad, Manisha Lamba

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 22% of its field
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.

NCT03803644 phase1completednot on this map

A Phase 1, Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dosing of CC-92480 and to Explore the Effect of Food on the Bioavailability of CC-92480 in Healthy Subjects

TypeinterventionalSponsorCelgeneRan2018 to 2019Enrolled56ConditionsHealthy VolunteerArmsCC-92480
NCT04211545 phase1completednot on this map

A Phase 1, Open-label Study to Assess the Single Dose Pharmacokinetics and Relative Bioavailability of a Test Capsule Formulation of CC-92480 Compared to a Reference CC 92480 Capsule Formulation and the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of CC 92480 From Test and Reference Formulations in Healthy Subjects

TypeinterventionalSponsorCelgeneRan2019 to 2019Enrolled24ConditionsHealthy VolunteerArmsRabeprazole, CC-92480
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Fan WuBristol Myers Squibb, Princeton, New Jersey, USA.
Liangang LiuBristol Myers Squibb, Princeton, New Jersey, USA.
Allison GaudyBristol Myers Squibb, Princeton, New Jersey, USA.
Xiaomin WangBristol Myers Squibb, Princeton, New Jersey, USA.
Leon CarayannopoulosBristol Myers Squibb, Princeton, New Jersey, USA.
Michael PourdehnadBristol Myers Squibb, Princeton, New Jersey, USA.
Manisha LambaBristol Myers Squibb, Princeton, New Jersey, USA.
Bristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mezigdomide is a novel cereblon E3 ligase modulator (CELMoD) agent with enhanced autonomous cell-killing activity in multiple myeloma (MM) cells, and promising immunomodulatory and antitumor activity in patients with MM. We developed a population pharmacokinetics (PKs) model for mezigdomide in healthy subjects (HSs), and quantified effects of high-fat meal and proton pump inhibitor (PPI) on human disposition parameters. Plasma concentrations from 64 HS in two phase I clinical studies (NCT03803644 and NCT04211545) were used to develop a population PK model. The HSs received single oral doses of 0.4-3.2 mg mezigdomide with full PK profiles collected. A two-compartment linear PK model with first-order absorption and lag time best described mezigdomide PK profiles in HSs. The population PK parameters of absorption rate constant, lag time, central volume of distribution, clearance, peripheral volume of distribution, and intercompartmental clearance were estimated to be 1.18 h

Indexed as

Immunosuppressive AgentsReducing AgentsAdministration, OralHumansImmunosuppressive AgentsReducing Agents

Identifiers

PMID37705327
PMCPMC10583261
OpenAlexW4386726290

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.