Trial reportJournal of clinical pharmacology2014
Tafenoquine at therapeutic concentrations does not prolong Fridericia-corrected QT interval in healthy subjects.
Trial report in Journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05203744 (Safety, Tolerability and Pharmacokinetics of Tafenoquine After Weekly and Escalating Monthly Doses of Tafenoquine in Healthy Vietnamese Volunteers), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled 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.
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.
Safety, Tolerability and Pharmacokinetics of Tafenoquine After Weekly and Escalating Monthly Doses of Tafenoquine in Healthy Vietnamese Volunteers
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Tafenoquine: a toxicity overview.Expert opinion on drug safety · 2021Pooled it
- Tafenoquine for preventing relapse in people with Plasmodium vivax malaria.The Cochrane database of systematic reviews · 2020Pooled it
- Tafenoquine for preventing relapse in people with Plasmodium vivax malaria.The Cochrane database of systematic reviews · 2015Pooled it
- Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound.The AAPS journal · 2018Trial
- Pharmacokinetic Interactions between Tafenoquine and Dihydroartemisinin-Piperaquine or Artemether-Lumefantrine in Healthy Adult Subjects.Antimicrobial agents and chemotherapy · 2016Trial
- Pharmacokinetic Models of Tafenoquine: Insights for Optimal Malaria Treatment Strategies.Pharmaceutics · 2024Review
- Tafenoquine for Relapsing Babesiosis: A Case Series.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Tafenoquine for the radical cureThe Indian journal of medical research · 2023Article
- Article
- The prevention and treatment of Plasmodium vivax malaria.PLoS medicine · 2021Article
- Safety and Efficacy of Tafenoquine forTherapeutics and clinical risk management · 2021Article
- Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review.Malaria journal · 2020Review
- Clinical utility of tafenoquine in the prevention of relapse ofInfection and drug resistance · 2019Review
- Population Pharmacokinetics of Tafenoquine, a Novel Antimalarial.Antimicrobial agents and chemotherapy · 2018Article
- Tafenoquine: First Global Approval.Drugs · 2018Review
- Estimation of QT interval prolongation through model-averaging.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- Interactions between tafenoquine and artemisinin-combination therapy partner drug in asexual and sexual stage Plasmodium falciparum.International journal for parasitology. Drugs and drug resistance · 2017Article
- New developments in anti-malarial target candidate and product profiles.Malaria journal · 2017Review
- Levofloxacin-Induced QTc Prolongation Depends on the Time of Drug Administration.CPT: pharmacometrics & systems pharmacology · 2016Article
- Tafenoquine and its potential in the treatment and relapse prevention of Plasmodium vivax malaria: the evidence to date.Drug design, development and therapy · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tafenoquine is being developed for relapse prevention in Plasmodium vivax malaria. This Phase I, single-blind, randomized, placebo- and active-controlled parallel group study investigated whether tafenoquine at supratherapeutic and therapeutic concentrations prolonged cardiac repolarization in healthy volunteers. Subjects aged 18-65 years were randomized to one of five treatment groups (n = 52 per group) to receive placebo, tafenoquine 300, 600, or 1200 mg, or moxifloxacin 400 mg (positive control). Lack of effect was demonstrated if the upper 90% CI of the change from baseline in QTcF following supratherapeutic tafenoquine 1200 mg versus placebo (ΔΔQTcF) was <10 milliseconds for all pre-defined time points. The maximum ΔΔQTcF with tafenoquine 1200 mg (n = 50) was 6.39 milliseconds (90% CI 2.85, 9.94) at 72 hours post-final dose; that is, lack of effect for prolongation of cardiac depolarization was demonstrated. Tafenoquine 300 mg (n = 48) or 600 mg (n = 52) had no effect on ΔΔQTcF. Pharmacokinetic/pharmacodynamic modeling of the tafenoquine-QTcF concentration-effect relationship demonstrated a shallow slope (0.5 ms/μg mL(-1) ) over a wide concentration range. For moxifloxacin (n = 51), maximum ΔΔQTcF was 8.52 milliseconds (90% CI 5.00, 12.04), demonstrating assay sensitivity. In this thorough QT/QTc study, tafenoquine did not have a clinically meaningful effect on cardiac repolarization.
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