Evidence map›Paper›PMID 28432691›Full record

ArticleBritish journal of clinical pharmacology2017

Tenapanor administration and the activity of the H

Susanne Johansson, David P Rosenbaum, Johan Palm, Bergur Stefansson, Mikael Knutsson, Eleanor A Lisbon, Constanze Hilgendorf

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02140281 (A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 45% 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.

NCT02140281 phase1completednot on this map

A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers

TypeinterventionalSponsorArdelyxRan2014 to 2014Enrolled71ConditionsHealthy VolunteersArmsTreatment A (cefadroxil alone), Treatment B - AZD1722 followed by cefadroxil
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. The Physiological Function and Potential Role of the Ubiquitous NaInternational journal of molecular sciences · 2022
    Review
  5. Article
  6. Tenapanor administration and the activity of the HBritish journal of clinical pharmacology · 2017
    Article
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 3 institutions in 3 countries.

Susanne JohanssonQuantitative Clinical Pharmacology, Innovative Medicines and Early Development Biotech Unit, AstraZeneca, Mölndal, Sweden.
David P RosenbaumArdelyx Inc., Fremont, CA, USA.ORCID http://orcid.org/0000-0002-9371-391X
Johan PalmProduct Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Mölndal, Sweden.
Bergur StefanssonCardiovascular Metabolic Diseases, Global Medicines Development, AstraZeneca, Mölndal, Sweden.
Mikael KnutssonBiometrics & Information Sciences, Global Medicines Development, AstraZeneca, Mölndal, Sweden.
Eleanor A LisbonQuintilesIMS, Overland Park, KS, USA.
Constanze HilgendorfDrug Metabolism and Pharmacokinetics, Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development Biotech Unit, AstraZeneca, Mölndal, Sweden.
AstraZeneca (Sweden) · SEArdelyx (United States) · USIQVIA (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTenapanor (RDX5791/AZD1722), an inhibitor of gastrointestinal Na

methodsIn this open-label, two-period crossover, phase 1 study (NCT02140281), 28 volunteers received in random order: a single dose of cefadroxil 500 mg for 1 day; and tenapanor 15 mg twice daily over 4 days followed by single doses of both cefadroxil 500 mg and tenapanor 15 mg on day 5. There was a 4-day washout between treatment periods.

resultsCefadroxil exposure was similar when administered alone or in combination with tenapanor {geometric least-squares mean ratios [(cefadroxil + tenapanor)/cefadroxil] (90% confidence interval): area under the concentration-time curve 93.3 (90.6-96.0)%; maximum concentration in plasma 95.9 (89.8-103)%}. Tenapanor treatment caused a softening of stool consistency and an increase in stool frequency, consistent with its expected pharmacodynamic effect. No safety concerns were identified and tenapanor was not detected in plasma.

conclusionsThese results suggest that tenapanor 15 mg twice daily does not have a clinically relevant impact on the activity of the H

Indexed as

Drug InteractionsAdultAnti-Bacterial AgentsCefadroxilCross-Over StudiesDrug Therapy, CombinationFemaleHealthy VolunteersHumansIsoquinolinesLaxativesMaleMiddle AgedPeptide Transporter 1SulfonamidesYoung AdultAnti-Bacterial AgentsCefadroxilIsoquinolinesLaxativesPeptide Transporter 1SLC15A1 protein, humanSulfonamidestenapanorcefadroxildrug interactionsPepT1sodium-hydrogen exchanger 3tenapanor

Identifiers

PMID28432691
PMCPMC5582369
OpenAlexW2606254265

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.