Evidence map›Paper›PMID 23701202›Full record

Trial reportBritish journal of clinical pharmacology2013

Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects.

Ann K Miller, Emma Harrell, Li Ye, Sharon Baptiste-Brown, Jőrg-Peter Kleim, Colin Ohrt, Stephan Duparc, Jörg J Möhrle, Alison Webster, Sandra Stinnett and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00871156 (Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT00871156 phase1completednot on this map

Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2009Enrolled68ConditionsMalariaArmsChloroquine, Tafenoquine, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Tafenoquine: a toxicity overview.Expert opinion on drug safety · 2021
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Tafenoquine forThe Indian journal of medical research · 2021
    Review
  11. Article
  12. Article
  13. Review
  14. Relapses ofBMJ global health · 2021
    Article
  15. Safety and Efficacy of Tafenoquine forTherapeutics and clinical risk management · 2021
    Article
  16. Review
  17. Review
  18. Article
  19. Tafenoquine and G6PD: a primer for clinicians.Journal of travel medicine · 2019
    Review
  20. 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

13 authors at 6 institutions in 2 countries.

Ann K MillerGSK, King of Prussia, PA, USA.
Emma Harrell
Li Ye
Sharon Baptiste-Brown
Jőrg-Peter Kleim
Colin Ohrt
Stephan Duparc
Jörg J Möhrle
Alison Webster
Sandra Stinnett
Arlene Hughes
Sandy Griffith
Andrew P Beelen
Guided Systems Technologies (United States) · USResearch Triangle Park Foundation · USDE Technologies (United States) · USMedicines for Malaria Venture · CHGlaxoSmithKline (United States) · USWalter Reed Army Institute of Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe long-acting 8-aminoquinoline tafenoquine (TQ) coadministered with chloroquine (CQ) may radically cure Plasmodium vivax malaria. Coadministration therapy was evaluated for a pharmacokinetic interaction and for pharmacodynamic, safety and tolerability characteristics.

methodsHealthy subjects, 18-55 years old, without documented glucose-6-phosphate dehydrogenase deficiency, received CQ alone (days 1-2, 600 mg; and day 3, 300 mg), TQ alone (days 2 and 3, 450 mg) or coadministration therapy (day 1, CQ 600 mg; day 2, CQ 600 mg + TQ 450 mg; and day 3, CQ 300 mg + TQ 450 mg) in a randomized, double-blind, parallel-group study. Blood samples for pharmacokinetic and pharmacodynamic analyses and safety data, including electrocardiograms, were collected for 56 days.

resultsThe coadministration of CQ + TQ had no effect on TQ AUC0-t , AUC0-∞ , Tmax or t1/2 . The 90% confidence intervals of CQ + TQ vs. TQ for AUC0-t , AUC0-∞ and t1/2 indicated no drug interaction. On day 2 of CQ + TQ coadministration, TQ Cmax and AUC0-24 increased by 38% (90% confidence interval 1.27, 1.64) and 24% (90% confidence interval 1.04, 1.46), respectively. The pharmacokinetics of CQ and its primary metabolite desethylchloroquine were not affected by TQ. Coadministration had no clinically significant effect on QT intervals and was well tolerated.

conclusionsNo clinically significant safety or pharmacokinetic/pharmacodynamic interactions were observed with coadministered CQ and TQ in healthy subjects.

Indexed as

AminoquinolinesAntimalarialsChloroquineAdministration, OralAdolescentAdultArea Under CurveDouble-Blind MethodDrug InteractionsDrug Therapy, CombinationFemaleGlucosephosphate DehydrogenaseHumansMaleMiddle AgedPolymorphism, Single NucleotideAminoquinolinesAntimalarialsChloroquineGlucosephosphate Dehydrogenasetafenoquinechloroquinemalariapharmacokineticsradical curetafenoquine

Identifiers

PMID23701202
PMCPMC3845309
OpenAlexW1519586906

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.