Evidence map›Paper›PMID 32578227›Full record

ArticleJournal of clinical pharmacology2020

The Effect of GS-548351 on the Pharmacokinetics of Midazolam Following Multiple Doses of ANS-6637 in Healthy Adults.

Haden T Bunn, Elana Rosenthal, Poonam Mathur, Mary McLaughlin, Michael Proschan, Arjun Vijan, Julia Aepfelbacher, Shyamasundaran Kottilil, Henry Masur, Sarah Kattakuzhy and 1 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 91% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Pooled it
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

11 authors at 5 institutions in 2 countries.

Haden T BunnClinical Pharmacokinetics Research Laboratory, Clinical Center Pharmacy Department, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.ORCID 0000-0003-2877-1627
Elana RosenthalInstitute of Human Virology, Division of Clinical Care and Research, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Poonam MathurInstitute of Human Virology, Division of Clinical Care and Research, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Mary McLaughlinNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Michael ProschanNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Arjun VijanNeurocrine Biosciences, San Diego, California, USA.
Julia AepfelbacherCritical Care Medicine Department, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Shyamasundaran KottililInstitute of Human Virology, Division of Clinical Care and Research, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Henry MasurCritical Care Medicine Department, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Sarah KattakuzhyInstitute of Human Virology, Division of Clinical Care and Research, Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Jomy M GeorgeClinical Pharmacokinetics Research Laboratory, Clinical Center Pharmacy Department, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
University of Maryland, Baltimore · USNational Institutes of Health Clinical Center · USNational Institutes of Health · USInstitute of Oriental Manuscripts · RUNeurocrine Biosciences (United States) · US

Funding

Pittsburgh HIV Mentored Training for Investigation of Co-morbidities and Cure (HIV MeTrICC)K12HL143886 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MELLORS, JOHN W, MORRIS, ALISON · 2018 to 2022
$1.7M
Ghana-SPARCO: Ghana Sickle Pan-African Research ConsortiumU01HL157004 · NHLBI · KWAME NKRUMAH UNIVERSITY/SCIENCE/TECH · PI OFORI-ACQUAH, SOLOMON FIIFI, SARFO, FRED STEPHEN · 2021 to 2025
$1.4M
Reducing the Impact of Opioid Use Disorder on the Acquisition and Management of HIV and on Comorbidities (SEARCH)ZIACL090058 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2019 to 2025
$0k
Intramural NIH HHS ZIA CL090058NHLBI NIH HHS K12 HL143886NHLBI NIH HHS U01 HL157004
6 · The paper itself

Abstract

ANS-6637, a pro-drug of GS-548351, is a selective, reversible inhibitor of aldehyde dehydrogenase isoform 2 under development as an anticraving agent for the treatment of substance use disorders. In vitro testing indicates that GS-548351 is an inhibitor and inducer of cytochrome P450 family 3, subfamily A (CYP3A). In this phase 1 single-center, open-label, fixed-sequence drug-drug interaction study we assessed the impact of steady-state GS-548351 on single-dose pharmacokinetics of midazolam, an index substrate for CYP3A. Twelve healthy volunteers received 600 mg of ANS-6637 by mouth daily from study days 3 to 8 and a single 5-mg oral dose of midazolam on days 1 and 8. Pharmacokinetic samples were collected over 24 hours on days 1 and 8, then analyzed using liquid chromatography-tandem mass spectrometry. The prespecified no-effect range for the 90% confidence interval (CI) of the geometric mean ratio (GMR) of midazolam coadministered with ANS-6637 (day 8) compared with midazolam alone (day 1) was 0.7-1.43. There was an increase in midazolam AUC

Indexed as

Administration, OralAdultAldehyde DehydrogenaseArea Under CurveCytochrome P-450 CYP3ADrug Administration ScheduleDrug InteractionsEnzyme InhibitorsFemaleHalf-LifeHealthy VolunteersHumansMaleMidazolamOrganic ChemicalsProdrugs1-hydroxymethylmidazolamAldehyde DehydrogenaseCYP3A4 protein, humanCytochrome P-450 CYP3AEnzyme InhibitorsGS-548351MidazolamOrganic ChemicalsProdrugsdrug-drug interactionsopioid usepharmacokineticssubstance use

Identifiers

PMID32578227
PMCPMC10833274
OpenAlexW3037832408

What OpenQuestion holds

Textmetadata
LicenceTDM
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.