Leishmaniasis drug candidate tested in humans for first time – study halted early
NCT ID NCT04504435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This was a first-in-human study to check the safety and how the body processes a single dose of GSK3494245, a potential treatment for leishmaniasis. It involved 59 healthy adults who received up to three increasing doses of the drug or a placebo. The study was terminated early, so the full safety and dosing information was not collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GSK3494245
- What could go wrong
- This was a very early, first-in-human study that was terminated, so we don't know if the drug is safe or effective. No conclusions can be drawn about treating leishmaniasis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
59 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Jan 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria * Participant must have been 18 to lesser than or equal to (\<=) 55 years of age, at the time of signing the informed consent. * Participant must have been healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) which was/were not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may have been included only if the Investigator in consultation with the Medical Monitor (if required) agreed and documented that the finding was unlikely to introduce additional risk factors and was not going to interfere with the study procedures. * Body weight greater than or equal to (\>=) 50 kg and body mass index (BMI) within the range 18.5-28 kg per meter square (kg/m\^2) (inclusive). * Male participants only. A male participant with a female partner of reproductive potential must have agreed to use contraception during the intervention period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and protocol. Exclusion criteria * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. * Abnormal blood pressure, as determined by the investigator. * Previous history of leishmaniasis. * Alanine transaminase (ALT) greater than (\>) upper limit of normal (ULN) at screening or Day - 1. Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN was acceptable if total bilirubin was fractionated and direct bilirubin less than (\<) 35 percent \[%\]). * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Current or history of clinically significant gastritis or gastroduodenal ulcers or regular use of non-steroidal anti-inflammatory drugs (NSAID). * Consumption of more than 14 units/week alcohol. * Current or history of change in taste or smell without any plausible clinical explanation based on investigator's clinical judgement. * QTc \>450 milliseconds (msec) based on average of triplicate ECGs. * Waveform abnormalities including premature ventricular contraction (PVC) triplets and more than 500 single PVCs in 24 hours, or any other abnormalities at the discretion of investigator. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. * Past or intended use of over-the-counter or prescription medication, including herbal medications, NSAIDs, proton pump inhibitors (PPIs) or anti-histamine 2 receptor (H2) antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may have been considered on a case by case basis by the investigator in consultation with the medical monitor. Paracetamol is permitted (capped to \<=2 grams/day). * Participation in the study that would result in loss of blood or blood products in excess of 500 mL within a 56-day period. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrollment or past participation in this clinical study. * Participants with renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) with an age appropriate Glomerular filtration rate (GFR) \<90 (milliliter per minute per 1.73 meter square \[mL/min/1.73m\^2\]). * Screening urine albumin: creatinine ratio \>30 milligram per gram (mg/g) (\>3 milligram per millimole \[mg/mmol\]) * Presence of hepatitis B surface antigen (HBsAg) test result at screening. * Positive hepatitis C antibody test result at screening. * Positive hepatitis C Ribonucleic acid (RNA) test result at screening. * Positive human immunodeficiency virus (HIV) antibody test. * Presence of clinically significant hematuria and/or proteinuria. * Carbon monoxide levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 3 months prior to screening. * Positive pre-study drug/alcohol screen. * Regular use of known drugs of abuse. * Fed regimens only: Participant must have had no dietary restrictions (e.g., lactose intolerance) or inability to eat an adapted standard meal (includes 35-40% fat content). * Fed regimen only: History of gall bladder surgery or gall bladder removal, or history of an acute disease state (e.g. cholelithiasis) within 14 days prior to receiving the study treatment. Inability to eat gelatin for bile sampling cohort. * Participants must not have travelled to an area (as determined by the investigator) with a high prevalence of leishmanial/parasitic infections in the 6 months before screening or intend to do so in the 3 months after the final dose of study treatment. * Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study. * A positive laboratory confirmation of corona virus disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
GSK Investigational Site
Cambridge, CB2 2GG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.