Evidence map›Paper›PMID 36763327›Full record

Trial reportClinical pharmacokinetics2023

Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study.

Antoine Tarral, Lionel Hovsepian, Thierry Duvauchelle, Yves Donazzolo, Mathilde Latreille, Mathieu Felices, Virginie Gualano, Sophie Delhomme, Olaf Valverde Mordt, Severine Blesson and 2 more

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

Trial report in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01533961 (Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
6.2field-weighted citation impact, top 3% 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.

NCT01533961 phase1completednot on this map

Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers

TypeinterventionalSponsorDrugs for Neglected DiseasesRan2012 to 2015Enrolled136ConditionsTrypanosomiasis, Trypanosomiasis, African, Protozoan Infections, Parasitic DiseasesArmsSCYX-7158, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Discovery of an Orally Efficacious Pyrazolo[3,4-Journal of medicinal chemistry · 2025
    Article
  10. Article
  11. 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

12 authors at 5 institutions in 3 countries.

Antoine TarralDrugs for Neglected Diseases initiative (DNDi), 15 Chemin Camille-Vidart, 1202, Geneva, Switzerland. atarral@dndi.org.ORCID 0000-0003-1247-8653
Lionel HovsepianPhase I Clinical Unit, SGS Aster, 3/5 rue Eugène Millon, 75015, Paris, France.
Thierry DuvauchellePhase I Clinical Unit, SGS Aster, 3/5 rue Eugène Millon, 75015, Paris, France.
Yves DonazzoloEurofins Optimed, 1 Rue des Essarts, 38610, Gières, France.
Mathilde LatreilleEurofins Optimed, 1 Rue des Essarts, 38610, Gières, France.
Mathieu FelicesPhinC Development, Genopole Campus 1, Immeuble Génavenir 8, 5 rue Henri Desbruères, 91000, Evry, France.
Virginie GualanoPhinC Development, Genopole Campus 1, Immeuble Génavenir 8, 5 rue Henri Desbruères, 91000, Evry, France.
Sophie DelhommeDrugs for Neglected Diseases initiative (DNDi), 15 Chemin Camille-Vidart, 1202, Geneva, Switzerland.
Olaf Valverde MordtDrugs for Neglected Diseases initiative (DNDi), 15 Chemin Camille-Vidart, 1202, Geneva, Switzerland.
Severine BlessonDrugs for Neglected Diseases initiative (DNDi), 15 Chemin Camille-Vidart, 1202, Geneva, Switzerland.
Pascal VoiriotCardiabase, Banook Group, 84 Avenue du XXème Corps, 54000, Nancy, France.
Nathalie Strub-WourgaftDrugs for Neglected Diseases initiative (DNDi), 15 Chemin Camille-Vidart, 1202, Geneva, Switzerland.
Drugs for Neglected Diseases Initiative · CHEuropean Organisation for Rare Diseases · FRGenopole (France) · FRSanofi (France) · FRThales (Australia) · AU

Funding

Gates Foundation INV-002384
6 · The paper itself

Abstract

BACKGROUND AND

objectivesAcoziborole is a novel boron-containing candidate developed as an oral drug for the treatment of human African trypanosomiasis (HAT). Results from preclinical studies allowed progression to Phase 1 trials. We aimed to determine the best dose regimen for all stages of HAT.

methodsAcoziborole was assessed in 128 healthy adult males of sub-Saharan African origin living in France. The study included a single oral administration of a 20- to 1200-mg dose in a randomised double-blind study in cohorts of 8 (6 active, 2 placebo) to assess safety, tolerability, and pharmacokinetics. In three additional open cohorts of 6 participants, the effect of activated charcoal was evaluated, bioequivalence of capsules versus tablets was assessed, and safety in the 960-mg tablet cohorts was monitored.

resultsAcoziborole was well tolerated at all doses tested; no dose-related adverse events were observed. The drug appeared rapidly in plasma (at 1 h), reached t

conclusionsThis study showed that acoziborole could be safely assessed in patients as a potential single-dose oral cure for both stages of gambiense HAT.

trial registrationThe study was registered with ClinicalTrials.gov: NCT01533961.

Indexed as

Antiprotozoal AgentsTrypanosomiasis, AfricanAdministration, OralAdultAnimalsArea Under CurveCross-Over StudiesHumansMaleTabletsTherapeutic EquivalencyAntiprotozoal AgentsTablets

Identifiers

PMID36763327
PMCPMC10042906
OpenAlexW4319827666

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.