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Cited by 3Pharmacology and Obesity TreatmentPharmacogenetics and Drug MetabolismDrug Solubulity and Delivery Systems

The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Effects of meal type on the bioavailability of vutiglabridin, a novel anti-obesity agent, in healthy subjects

Open access
Won, Heejae, Yoon, Deok Yong, Lee, Sangmi, Cho, Joo‐Youn, Oh, Jaeseong, Jang, In‐Jin, Yoo, Sang‐Ku, Yu, Kyung‐Sang·2024·Clinical and Translational Science
DOI 10.1111/cts.13744PMC PMC10910614
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Abstract

Vutiglabridin, which affects the pharmacokinetics (PKs) of food, is currently under clinical development for the treatment of obesity. This study aimed to evaluate the effects of low‐ and high‐fat meals on PKs of vutiglabridin in healthy male subjects. A randomized, open‐label, single‐dose, three‐period, six‐sequence crossover study was conducted. The subjects received a single oral dose of vutiglabridin 480 mg in a fasted state, 30 min after the intake of a low‐fat meal (total 500–600 kcal, fat content 100–125 kcal) and high‐fat meal (total 800–1000 kcal, fat content 500–600 kcal), with a 21‐day washout period. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for maximum plasma concentration (Cmax) and area under the plasma concentration‐time curve to the last measurable timepoint (AUC last) were calculated. After intake of low‐ and high‐fat meals, systemic exposure to vutiglabridin was increased, and the time to reach Cmax (Tmax) was delayed compared to that in the fasted state. The GMRs (90% CIs) of low‐fat meal to fasted state for Cmax and AUC last were 2.14 (1.76–2.60) and 2.15 (1.92–2.42), respectively, and those of high‐fat meal to fasted state were 3.07 (2.53–3.72) and 3.00 (2.67–3.37), respectively. The median Tmax was delayed by 1.5 h in both fed states compared with that in the fasted state. The study drug was well‐tolerated after administration in both the fed and fasted states. Food ingestion substantially increased the extent of oral vutiglabridin absorption in healthy subjects, and this enhancement increased with the fat content of the meal.

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Registry

Crossref · 10.1111/cts.13744

Cites

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Figures

FIGURE 1 Study design. Fasted, vutiglabridin 480 mg administration in fasted state; Low‐Fat, vutiglabridin 480 mg administration after the intake of low‐fat meal (total 500–600 kcal, fat content 100–125 kcal); High‐Fat, vutiglabridin 480 mg administration after the intake of high‐fat meal (total 800–1000 kcal, fat content 500–600 kcal); PK, pharmacokinetic.
FIGURE 1 Study design. Fasted, vutiglabridin 480 mg administration in fasted state; Low‐Fat, vutiglabridin 480 mg administration after the intake of low‐fat meal (total 500–600 kcal, fat content 100–125 kcal); High‐Fat, vutiglabridin 480 mg administration after the intake of high‐fat meal (total 800–1000 kcal, fat content 500–600 kcal); PK, pharmacokinetic.CC BY-NC-ND · PubMed Central
FIGURE 2 Mean plasma concentration‐time profiles of vutiglabridin after a single oral administration in high‐fat, low‐fat and fasted states. (a) linear scale (plasma concentration‐time profiles until 24 h are inserted as inset figures), (b) semi‐log scale.
FIGURE 2 Mean plasma concentration‐time profiles of vutiglabridin after a single oral administration in high‐fat, low‐fat and fasted states. (a) linear scale (plasma concentration‐time profiles until 24 h are inserted as inset figures), (b) semi‐log scale.CC BY-NC-ND · PubMed Central
FIGURE 3 Individual pharmacokinetic parameters of vutiglabridin in high‐fat, low‐fat and fasted states. (a) C max, (b) AUClast. C max, maximum plasma concentration; AUClast, area under concentration‐time curve from 0 to last measurable timepoint.
FIGURE 3 Individual pharmacokinetic parameters of vutiglabridin in high‐fat, low‐fat and fasted states. (a) C max, (b) AUClast. C max, maximum plasma concentration; AUClast, area under concentration‐time curve from 0 to last measurable timepoint.CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 2

  1. Sombra LRS, 2022, StatPearls
  2. Malcolm Rowland TNT, 2019, Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications

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Metadata

Authors
Won, H., Yoon, D. Y., Lee, S., Cho, J., Oh, J., Jang, I., Yoo, S., & Yu, K.
Affiliations
  • Seoul National University (KR)
  • Glaceum (South Korea) (KR)
Corresponding author
Yu, Kyung‐Sang
ORCID
Venue
Clinical and Translational Science
Publisher
Wiley
Published
2024-03
Volume
17
Issue
3
Pages
e13744-e13744
ISSN
  • 1752-8054 (ISSN-L)
  • 1752-8062
DOI
10.1111/cts.13744
PMC
PMC10910614
OpenAlex
W4392376656
Cited by
3
References
21
Citations by year
2025: 2 · 2024: 1
FWCI
0.85
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical and Translational Science (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Keywords
food effect, high-fat meal, low-fat meal, pharmacokinetics, obesity, oral absorption, time to peak concentration, food-drug interactions, healthy volunteers
MeSH terms
Biological Availability, Humans, Male, Cross-Over Studies, Anti-Obesity Agents, Meals, Healthy Volunteers

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