Evidence map›Paper›PMID 37798608›Full record

Trial reportClinical drug investigation2023

A Phase 1 Study of Ensitrelvir Fumaric Acid Tablets Evaluating the Safety, Pharmacokinetics and Food Effect in Healthy Adult Populations.

Ryosuke Shimizu, Takuhiro Sonoyama, Takahiro Fukuhara, Aya Kuwata, Yumiko Matsuo, Ryuji Kubota

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Trial
  4. Article
  5. A SARS-CoV-2 MNature communications · 2025
    Article
  6. Discovery of the Clinical CandidateJournal of medicinal chemistry · 2025
    Article
  7. Review
  8. Article
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  10. Article
  11. Review
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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

6 authors.

Ryosuke ShimizuProject Management Division, Clinical Pharmacology and Pharmacokinetics Department, Shionogi & Co., Ltd, 8F, Nissay Yodoyabashi East, 3-3-13 Imabashi, Chuo-ku, Osaka, 541-0042, Japan. ryosuke.shimizu@shionogi.co.jp.
Takuhiro SonoyamaMedical Science Department, Shionogi & Co., Ltd, Osaka, Japan.
Takahiro FukuharaClinical Research Department, Shionogi & Co., Ltd, Osaka, Japan.
Aya KuwataClinical Research Department, Shionogi & Co., Ltd, Osaka, Japan.
Yumiko MatsuoProject Management Division, Clinical Pharmacology and Pharmacokinetics Department, Shionogi & Co., Ltd, 8F, Nissay Yodoyabashi East, 3-3-13 Imabashi, Chuo-ku, Osaka, 541-0042, Japan.
Ryuji KubotaProject Management Division, Clinical Pharmacology and Pharmacokinetics Department, Shionogi & Co., Ltd, 8F, Nissay Yodoyabashi East, 3-3-13 Imabashi, Chuo-ku, Osaka, 541-0042, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA reported clinical pharmacokinetics and safety study of suspension formulation of ensitrelvir, a therapeutic agent used in severe acute respiratory syndrome coronavirus 2 infection, demonstrated favorable pharmacokinetics and was well tolerated in healthy male Japanese and White participants. Understanding the safety and pharmacokinetic features of ensitrelvir (using the formulation approved for clinical use) in various populations, and the effect of food, is crucial for optimal clinical use.

objectivesThe objectives of this study were to (1) assess the safety, tolerability, and pharmacokinetics of ensitrelvir following multiple-dose administration of ensitrelvir tablets in populations with different races, ages, and sex; and (2) assess the effect of food on the pharmacokinetics of ensitrelvir tablets in the fasted or fed state.

methodsA phase 1, multicenter, double-blinded, randomized, placebo-controlled study was conducted to evaluate the safety and pharmacokinetics of once-daily ensitrelvir tablets at loading/maintenance doses of 375/125 mg or 750/250 mg for 5 days in healthy Japanese females, Japanese elderly (only 375/125 mg), and White male and female participants. An open-label, two-group, two-period crossover study was also conducted to estimate the effect of food on the pharmacokinetics of ensitrelvir at single dose of 375 mg. The nature, frequency, and severity of treatment-emergent adverse events were evaluated and recorded in safety assessments in both studies.

resultsThe maximum plasma concentration (C

conclusionEnsitrelvir (375/125 mg and 750/250 mg tablet formulation) was well tolerated, without any major safety concerns. The pharmacokinetics of ensitrelvir between all populations in the study were similar and C CLINICAL

trial registrationJapan Registry of Clinical Trials identifier: jRCT2031210202, registered on 16 July 2021.

Indexed as

COVID-19Administration, OralAdultAgedArea Under CurveCross-Over StudiesFemaleFumaratesHealthy VolunteersHumansIndazolesMaleTabletsTriazinesTriazolesensitrelvirFumaratesfumaric acidIndazolesTabletsTriazinesTriazoles

Identifiers

PMID37798608
PMCPMC10575992

What OpenQuestion holds

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Registered trials

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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.