Evidence map›Paper›PMID 39167148›Full record

Trial reportCancer chemotherapy and pharmacology2024

Relative bioavailability and food effect of the galectin-3 inhibitor selvigaltin (GB1211) administered as a tablet in healthy participants (GALBA-1).

Vassilios Aslanis, Khalid Abd-Elaziz, Robert J Slack, Anne Brinch, Lise Gravelle, Wayne Morley, De Phung, Kimberly Herman, Ian Holyer, Karen Killerup Poulsen and 6 more

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

Trial report in Cancer chemotherapy and pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05747573 (An Open-label, Randomized, Three-period, Crossover Study to Compare the Pharmacokinetics of GB1211 Upon Dosing a Capsule Under Fasting Condition and a Tablet Under Fasting and Fed Conditions in Healthy Volunteers), which is 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
–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.

NCT05747573 phase1completednot on this map

An Open-label, Randomized, Three-period, Crossover Study to Compare the Pharmacokinetics of GB1211 Upon Dosing a Capsule Under Fasting Condition and a Tablet Under Fasting and Fed Conditions in Healthy Volunteers

TypeinterventionalSponsorGalecto Biotech ABRan2023 to 2023Enrolled13ConditionsPharmacokineticsArmsGB1211
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. The Role of Galectin-3 in Liver Inflammation and Fibrosis.Journal of inflammation research · 2026
    Review
  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

16 authors.

Vassilios AslanisGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark. v.aslanis@gmail.com.ORCID 0000-0003-0997-0081
Khalid Abd-ElazizQPS Netherlands BV, Groningen, The Netherlands.ORCID 0000-0002-0964-4940
Robert J SlackGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.ORCID 0000-0002-4372-9438
Anne BrinchGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Lise GravelleGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Wayne MorleyGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
De PhungGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Kimberly HermanGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.ORCID 0000-0002-8672-0599
Ian HolyerGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Karen Killerup PoulsenGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Peter DogteromQPS Netherlands BV, Groningen, The Netherlands.
Susan TantawiGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.ORCID 0009-0000-7671-0568
Fredrik R ZetterbergGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.ORCID 0000-0002-7789-8782
Brian JacobyGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Hans SchambyeGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.
Bertil LindmarkGalecto Biotech AB, Ole Maaløes Vej 3, DK-2200, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOverexpression of galectin-3, a β-galactoside-binding lectin, is associated with fibrotic diseases and cancer. Selvigaltin is an oral galectin-3 inhibitor, previously administered as a 50 mg capsule. This study aimed to evaluate the relative bioavailability and food effect of selvigaltin as a 100 mg tablet in healthy volunteers.

methodsIn this single-dose, randomized, three-period, crossover study (GALBA-1; NCT05747573), participants received selvigaltin as a 100 mg tablet (under fasted and fed conditions) or as two 50 mg capsules (under fasted conditions). Primary endpoints included plasma and urine pharmacokinetic (PK) parameters. Secondary endpoints were safety and tolerability.

resultsOf the 13 enrolled participants, 12 completed the study. Under fasted conditions, geometric mean maximum observed plasma concentration (C

conclusionThe tablet formulation of selvigaltin displayed higher bioavailability vs. the capsule formulation, with minimal effect of food on PK. Selvigaltin was well-tolerated during all treatments. These findings warrant further clinical development of the tablet formulation of selvigaltin without specific food restrictions. CLINICAL

trial registrationNCT05747573; February 28, 2023.

Indexed as

Biological AvailabilityCross-Over StudiesFood-Drug InteractionsHealthy VolunteersTabletsAdministration, OralAdultArea Under CurveBlood ProteinsCapsulesFastingFemaleGalectin 3GalectinsHumansMaleBlood ProteinsCapsulesGalectin 3GalectinsLGALS3 protein, humanTabletsBioavailabilityFood effectGalectin-3SelvigaltinTablet formulation

Identifiers

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.