A Phase 1 interventional study of LXE408 and Placebo in Visceral Leishmaniasis and Chagas Disease, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Other
The purpose of this first-in-human study is to generate the necessary safety, tolerability, and pharmacokinetics (PK) information that will support further clinical development of LXE408 for the treatment of patients with visceral leishmaniasis and potentially Chagas disease.
68 studies on the registry are indexed under Leishmaniasis, Visceral; 7 are open to participants now.
This study's enrollment of 88 is below the median of 132 across 48 interventional studies indexed under Leishmaniasis, Visceral.
Browse Leishmaniasis, Visceral studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position. Sitting vital signs should be within the following ranges:
Exclusion Criteria:
A history of clinically significant abnormalities, or any of the following ECG abnormalities at screening or baseline:
Other protocol-defined inclusion/exclusion may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received a single ascending dose of LXE408 or Placebo (fasted).
Drug: LXE408 · Drug: Placebo
Participants received a single ascending dose of LXE408 or Placebo (fasted).
Drug: LXE408 · Drug: Placebo
Participants received a single ascending dose of LXE408 or Placebo (fasted and fed). This Cohort is divided into 2 parts: fasted and fed. Participants treated in cohort 3a (fasted) are mandated to return for cohort 3b (Food Effect) after at least a 7-day washout period between dosings.
Drug: LXE408 · Drug: Placebo
Participants received a single ascending dose of LXE408 or Placebo (fasted).
Drug: LXE408 · Drug: Placebo
Participants received a single ascending dose of LXE408 or Placebo (fasted).
Drug: LXE408 · Drug: Placebo
Participants received multiple ascending doses of LXE408 once daily or Placebo.
Drug: LXE408 · Drug: Placebo
Participants received multiple ascending doses of LXE408 once daily or Placebo.
Drug: LXE408 · Drug: Placebo
Participants received multiple ascending doses of LXE408 mg once daily or Placebo.
Drug: LXE408 · Drug: Placebo
Participants received multiple ascending doses of LXE408 once daily or Placebo.
Drug: LXE408 · Drug: Placebo
Participants in this Measured glomerular filtration rate (mGFR) cohort received multiple ascending doses of LXE408 and iohexol or Placebo and iohexol.
Drug: LXE408 · Drug: Placebo · Drug: Iohexol
Participants received multiple ascending doses of LXE408 once daily or Placebo.
Drug: LXE408 · Drug: Placebo
LXE408 comes in film coated tablets and is taken orally.
LXE408 matching placebo comes in film coated tablets and is taken orally.
Iohexol is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 and is administered to the participant via intravenous (IV) injection.
Parts A & B: Number of participants with Adverse Events, physical exam findings, vital signs, ECG findings, safety laboratory assessments including chemistry, hematology, and urinalysis results
To assess the safety and tolerability of of single and multiple ascending oral doses of LXE408.
Time frame: Part A: Single Ascending Dose (SAD): 35 days; Part A: SAD (Food Effect): 63 days; Part B: Multiple Ascending Dose (MAD): 45 days
Pharmacokinetics (PK) of LXE408 and its metabolite MAN519: AUC (AUC0-24; AUCtau, AUClast, AUCinf as relevant) Parts A (SAD) & B (MAD)
AUC, Area under Curve, represents the total amount of a drug that is actively present in the body over a specific period.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
Pharmacokinetics of MAN519: Metabolite to parent ratio (MPTR) for AUC: MTPR_AUC
Metabolite-to-parent AUC ratio is the ratio of the overall exposure to a metabolite compared with the overall exposure to the parent drug.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
PK of LXE408 and its metabolite (MAN519) Parts A & B: Tmax
Tmax, Time to Maximum, refers to the time required for a drug to reach its maximum concentration in the body.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
PK of LXE408 and its metabolite (MAN519) Parts A & B: Cmax
Cmax, the maximum plasma concentration, is the highest peak concentration of a drug observed in the body's systemic circulation.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
PK of LXE408 Parts A & B: CL/F
CL/F (Apparent Clearance) represents the efficiency of drug removal from the body following extravascular administration.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
PK of LXE408 Parts A & B: V/F
V/F represents the apparent volume of distribution for a drug administered through a non-intravenous route.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
PK of LXE408 Part A (excluding Cohort 3b, Food effect cohort): Ae
Ae stands for the cumulative amount of an unchanged drug excreted in the urine. It is a critical parameter used to measure how much of the active, unmetabolized medication is expelled from the body via the kidneys over a specific period of time.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A
PK of LXE408 Part A (excluding Cohort 3b, Food effect cohort): CLR
CLR stands for renal clearance. It is the volume of plasma completely cleared of a drug by the kidneys per unit of time. It represents the rate at which the kidneys filter, secrete, and excrete a specific medication into the urine.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A
PK of LXE408 and its metabolite (MAN519) Parts A & B: T1/2
T1/2 (half-life) is the time required for the concentration of a drug in the body or bloodstream to reduce by exactly 50%.
Time frame: up to 72 hours post-dose for plasma PK in Part A, 48 hours post-dose for urine PK in Part A and and Intensive PK samples for 24 hours post dose on Day 1 and 10 and trough samples from Day 2 to Day 9, in Part B
Plasma clearance of iohexol (measured glomerular filtration rate (mGFR) cohort) (Part B only)
To measure renal function (glomerular filtration rate (GFR)) after administration of LXE408.
Time frame: Day -1 (before LXE408 administration), Day 5 & Day 10 (Post LXE408 administration) at 0,0.5,1,2,3,4,6,8,10,12 hours (post- iohexol dose)
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: LXE408