Evidence map›Paper›PMID 40304628›Full record

Trial reportClinical and translational science2025

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INT-787, a Novel Farnesoid X Receptor Agonist, in Healthy Volunteers: A Phase 1 Trial.

Thomas Capozza, Jennifer Burkey, Jeroen Van De Wetering, Reinhold Kerb, Jennifer Callahan, Ludmila Kryzhanovskaya, Mary Erickson

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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.

Thomas CapozzaIntercept Pharmaceuticals, Inc, Morristown, New Jersey, USA.
Jennifer BurkeyIntercept Pharmaceuticals, Inc, Morristown, New Jersey, USA.
Jeroen Van De WeteringICON, Groningen, the Netherlands.
Reinhold KerbICON, Mannheim, Germany.
Jennifer CallahanIntercept Pharmaceuticals, Inc, Morristown, New Jersey, USA.
Ludmila KryzhanovskayaIntercept Pharmaceuticals, Inc, Morristown, New Jersey, USA.
Mary EricksonIntercept Pharmaceuticals, Inc, Morristown, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aberrant farnesoid X receptor (FXR) signaling is implicated in cholestatic, inflammatory, and fibrotic liver diseases. In preclinical/clinical studies, semisynthetic bile acid-derived FXR agonists markedly improved hepatic function in various conditions. INT-787, a novel hydrophilic semisynthetic bile acid FXR agonist, has demonstrated a reduction in inflammatory and fibrotic markers and regulation of bile acid/lipid metabolism. This first-in-human, randomized, placebo-controlled phase 1 study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of INT-787 and its equipotent metabolites in healthy volunteers by evaluating single ascending doses (SAD), multiple ascending doses (MAD), and food effect. Participants (n = 130) across all study portions were similar in age, race, and body mass index. In the SAD and MAD portions, the maximum plasma concentration (C

Indexed as

Receptors, Cytoplasmic and NuclearAdministration, OralAdolescentAdultArea Under CurveBile Acids and SaltsDose-Response Relationship, DrugDouble-Blind MethodFemaleFibroblast Growth FactorsFood-Drug InteractionsHealthy VolunteersHumansMaleMiddle AgedReceptor, Farnesoid X-ActivatedBile Acids and SaltsFibroblast Growth FactorsReceptor, Farnesoid X-ActivatedReceptors, Cytoplasmic and NuclearINT‐787liver disordersmetabolic dysfunction–associated steatohepatitispharmacodynamicspharmacokineticssafetytolerability

Identifiers

PMID40304628
PMCPMC12042697

What OpenQuestion holds

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LicenceCC BY-NC
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.