Evidence map›Paper›PMID 40146460›Full record

ArticleClinical pharmacokinetics2025

Pharmacokinetics and Safety of Navitoclax in Hepatic Impairment.

Maulik Patel, Jalaja Potluri, Thomas Marbury, Eric Lawitz, Juan Carlos Rondon, David M Hoffman, Satya R Siddani, Kennan C Marsh, Elaine J Kim, Muhammad Erfan Uddin and 2 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

12 authors.

Maulik PatelClinical Pharmacology, AbbVie Inc, South San Francisco, CA, USA.
Jalaja PotluriAbbVie Inc, North Chicago, IL, USA.
Thomas MarburyOrlando Clinical Research Center, Orlando, FL, USA.
Eric LawitzTexas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.
Juan Carlos RondonClinical Pharmacology of Miami, Miami, FL, USA.
David M HoffmanAbbVie Inc, North Chicago, IL, USA.
Satya R SiddaniAbbVie Inc, North Chicago, IL, USA.
Kennan C MarshAbbVie Inc, North Chicago, IL, USA.
Elaine J KimAbbVie Inc, North Chicago, IL, USA.
Muhammad Erfan UddinAbbVie Inc, North Chicago, IL, USA.
Rajeev M MenonAbbVie Inc, North Chicago, IL, USA.
Akshanth R PolepallyClinical Pharmacology, AbbVie Inc, South San Francisco, CA, USA. akshanth.r.polepally@abbvie.com.ORCID 0000-0002-5938-6062

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveNavitoclax, an orally bioavailable B-cell lymphoma-2 (Bcl-2) family protein inhibitor, inhibits antiapoptotic Bcl-2 family proteins (with high affinity to Bcl-XL, Bcl-2, and Bcl-W). Navitoclax in combination with ruxolitinib has been investigated to treat patients with myelofibrosis (MF).

methodsSince navitoclax undergoes hepatic metabolism, we evaluated the pharmacokinetics (PK) and safety of single-dose navitoclax 50 mg in a phase 1 study in participants with mild (N = 6), moderate (N = 6), or severe (N = 1) hepatic impairment and matched participants with normal hepatic function (N = 7). All participants in this study were enrolled per Child-Pugh classification, with demographics matched per age, weight, and race.

resultsNavitoclax maximum plasma concentration (C

conclusionsIn summary, no new safety issues were identified. On the basis of the pharmacokinetic results, no dose adjustment is required for patients with MF with mild or moderate hepatic impairment.

Indexed as

Aniline CompoundsLiver DiseasesSulfonamidesAdultAgedArea Under CurveFemaleHalf-LifeHumansMaleMiddle AgedProto-Oncogene Proteins c-bcl-2Aniline CompoundsnavitoclaxProto-Oncogene Proteins c-bcl-2Sulfonamides

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.