Trial reportClinical and translational science2025
Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects.
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. It is linked to trial NCT04645940 (A Phase 1, Open-Label, 3 Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of Fruquintinib in Healthy Subjects), which is not on this map. Cited by 3 papers.
What it found
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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.
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.
A Phase 1, Open-Label, 3 Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of Fruquintinib in Healthy Subjects
Who cites it
3 citing papers in PubMed.
- Fruquintinib: Mechanism of Action, Clinical, and Translational Science.Clinical and translational science · 2026Review
- A Phase 1 Study to Assess the Effect of Fruquintinib on the Pharmacokinetics of P-gp and BCRP Substrates in Healthy Subjects.Clinical and translational science · 2025Article
- Effects of Hepatic or Renal Impairment on Pharmacokinetics of Fruquintinib.Journal of clinical pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This two-sequence, three-period study (NCT04645940) was designed to evaluate the effect of food and concomitant rabeprazole, a proton pump inhibitor, on the pharmacokinetics (PK) and safety of fruquintinib and its metabolite M11 after a single oral dose of fruquintinib 5 mg in healthy subjects. In the food effect treatment periods, 14 subjects were randomized in a 1:1 ratio utilizing a two-sequence (fed/fasted vs. fasted/fed), two-period, cross-over design. Fruquintinib was administered on Day 1 (Period 1) and Day 15 (Period 2). In the drug-interaction period (Period 3), all subjects received rabeprazole 40 mg 1 h prior to fruquintinib under fasted conditions, following a 6-day lead-in of rabeprazole 40 mg once daily. PK samples to measure fruquintinib and M11 were collected pre-dose and over 168 h after fruquintinib dosing. Administration of fruquintinib with a high-fat meal resulted in similar systemic exposure compared with fasted conditions. In addition, coadministration of fruquintinib with rabeprazole resulted in similar exposure compared with fruquintinib alone. For both evaluations, 90% confidence intervals for the ratio of geometric least square mean of the area under the curve and peak concentration for fruquintinib and M11 were entirely within 80%-125% bounds. The study results showed no effects of food or rabeprazole on fruquintinib PK, and support that fruquintinib can be taken without regard to food or concurrent gastric acid-reducing agents.
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Registered trials
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