Evidence map›Paper›PMID 36824016›Full record

Trial reportClinical and translational science2023

Effect of food on the pharmacokinetics of zoliflodacin granules for oral suspension: Phase I open-label randomized cross-over study in healthy subjects.

Alison Luckey, Emilie Alirol, Sophie Delhomme, John O'Donnell, Esther Bettiol, John Mueller, Seamus O'Brien, Jean-Yves Gillon

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 29% of its field
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

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Journal of clinical medicine · 2023
    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

8 authors at 3 institutions in 2 countries.

Alison LuckeyGARDP, Geneva, Switzerland.ORCID 0000-0002-5831-8914
Emilie AlirolGARDP, Geneva, Switzerland.ORCID 0000-0001-8691-3991
Sophie DelhommeDNDi, Geneva, Switzerland.
John O'DonnellEntasis Therapeutics, Waltham, Massachusetts, USA.
Esther BettiolGARDP, Geneva, Switzerland.
John MuellerEntasis Therapeutics, Waltham, Massachusetts, USA.
Seamus O'BrienGARDP, Geneva, Switzerland.
Jean-Yves GillonDNDi, Geneva, Switzerland.
Global Antibiotic Research & Development Partnership · CHDrugs for Neglected Diseases Initiative · CHEntasis Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Gonorrhea is a sexually transmitted infection for which antibiotic treatment options have declined due to increasing antibiotic resistance. Zoliflodacin, an investigational oral spiropyrimidinetrione antibiotic with activity against Neisseria gonorrhoeae strains that are multidrug-resistant, including to third-generation cephalosporins, is in phase III development for uncomplicated gonorrhea. This phase I, parallel, open-label, randomized, crossover study in healthy adults evaluated the effect of food on the pharmacokinetics of single 3 or 4 g doses of zoliflodacin administered as granules for oral suspension in the fasted state or after consumption of a standardized high-fat meal. Forty-seven out of 48 randomized subjects completed the study. Oral administration of zoliflodacin with food delayed the absorption rate, compared with fasted state, with time to maximum concentration (T

Indexed as

GonorrheaOxazolidinonesAdministration, OralAdultAnti-Bacterial AgentsBarbituratesCross-Over StudiesHealthy VolunteersHumansIsoxazolesMorpholinesSpiro CompoundsAnti-Bacterial AgentsBarbituratesIsoxazolesMorpholinesOxazolidinonesSpiro Compoundszoliflodacin

Identifiers

PMID36824016
PMCPMC10176008
OpenAlexW4321748808

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.