Evidence map›Paper›PMID 33420642›Full record

Trial reportInvestigational new drugs2021

Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers.

Lei Li, Yu-Xia Xiang, Guo-Ping Yang, Xing-Fei Zhang, Xiao-Yan Yang, Shuang Yang, Jie Huang

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04108676 (a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

NCT04108676 phase1completednot on this map

a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2019 to 2019Enrolled16ConditionsAdvanced Solid TumorArmsFluzoparib, Omeprazole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

7 authors at 2 institutions in 1 country.

Lei LiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Yu-Xia XiangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Guo-Ping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Xing-Fei ZhangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Xiao-Yan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China. cellahuang1988@163.com.
Third Xiangya Hospital · CNCentral South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose To assess the pharmacokinetic (PK) effect of proton pump inhibitors on the novel poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor fluzoparib, and observe the safety of its co-administration with omeprazole. Patients and methods Sixteen male healthy volunteers (HVs) were enrolled in a single-center, single-arm, open-label, fixed-sequence study. HVs took fluzoparib (100 mg, p.o.) after meal consumption on day-1, took omeprazole 40 mg (p.o.) under a fasting condition from day-5 to day-9, and took fluzoparib (100 mg, p.o.) after meal consumption on day-9. Blood samples were collected at predetermined timepoints for PK analyses. Safety was assessed via clinical laboratory tests. The study was registered with the Clinical Trials Registry on 30 September 2019 (NCT04108676). Results The peak plasma concentrations (C

Indexed as

Antineoplastic AgentsOmeprazolePhthalazinesPoly(ADP-ribose) Polymerase InhibitorsProton Pump InhibitorsAdministration, OralAdolescentAdultHealthy VolunteersHumansMaleMiddle AgedYoung AdultAntineoplastic AgentsfluzoparibOmeprazolePhthalazinesPoly(ADP-ribose) Polymerase InhibitorsProton Pump InhibitorsDrug–drug interactionPARP inhibitorPharmacokineticsProton pump inhibitorSafety

Identifiers

PMID33420642
OpenAlexW3120408590

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.