Visceral LeishmaniasisPhase 1NCT07809919
A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects
A Phase 1 study testing LXE408 and Iohexol in people with Visceral Leishmaniasis and Chagas Disease, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Leishmaniasis, Chagas Disease
- What is being tested?
- LXE408 and Iohexol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2018to 27 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Healthy male and female subjects 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline.
- 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:
- oral body temperature between 35.0-37.5 °C
- systolic blood pressure between 90-139 mmHg
- diastolic blood pressure between 50-89 mmHg
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- pulse rate between 40-90 bpm
- Subjects must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18 - 30 kg/m2. [BMI = Body weight (kg) / [Height (m)]2]
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Known history or current clinically significant cardiac arrhythmias.
- Significant illness which has not resolved within two (2) weeks prior to baseline.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
- Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded.
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- Known family history or known presence of long QT syndrome.
- History of immunodeficiency diseases, or a positive HIV (screening and confirmatory) test result.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Donation or loss of 450 mL or more of blood within eight weeks prior to baseline, or longer if required by local regulation.
- Plasma donation (450 mL) within 8 weeks prior to baseline.
- Hemoglobin levels or platelet counts below the lower limit of normal for the laboratory.
- History of drug abuse or unhealthy alcohol use within the 12 months prior to baseline, or evidence of such abuse as indicated by the laboratory assays conducted during screening #Unhealthy alcohol use is defined as a history of, or current alcohol misuse/abuse, defined as "Five or more drinks on the same occasion on each of 5 or more days in the past 30 days."
- History of recreational cannabis use within four weeks prior to baseline. This exclusion criterion applies even if cannabis use is legalized where the site is located.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline:
- PR > 200 msec
- QRS complex > 120 msec
- QTcF > 450 msec (males)
- QTcF > 460 msec (females)
- Pregnant or nursing (lactating) women.
- Smokers based on urine cotinine levels. Urine cotinine levels will be measured during screening and at each baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL.
- Other protocol-defined inclusion/exclusion may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates PA and Vince and Associates Inc
Overland Park, Kansas, 66212
About this study
Official title: A First-in-human, Randomized, Subject Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LXE408 in Healthy Subjects
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.
- Conditions
- Visceral Leishmaniasis, Chagas Disease
- Being tested
- LXE408, Placebo, Iohexol
- Keywords
- LXE408, first-in-human study, Phase l, First-in-human, healthy subject, single ascending dose, multiple ascending dose, visceral leishmaniasis
- Medical subject headings
- Leishmaniasis, Visceral, Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXE408Drug
LXE408 comes in film coated tablets and is taken orally.
PlaceboDrug
LXE408 matching placebo comes in film coated tablets and is taken orally.
IohexolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Single Ascending Dose (SAD): Cohort 1: LXE408/Placebo | Experimental | Participants received a single ascending dose of LXE408 or Placebo (fasted). Receives: Drug: LXE408; Drug: Placebo |
| Part A - SAD: Cohort 2: LXE408 /Placebo | Experimental | Participants received a single ascending dose of LXE408 or Placebo (fasted). Receives: Drug: LXE408; Drug: Placebo |
| Part A - SAD: Cohort 3a/b: LXE408/Placebo | Experimental | 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. Receives: Drug: LXE408; Drug: Placebo |
| Part A - SAD: Cohort 4: LXE408/Placebo | Experimental | Participants received a single ascending dose of LXE408 or Placebo (fasted). Receives: Drug: LXE408; Drug: Placebo |
| Part A - SAD: Cohort 5: LXE408/Placebo | Experimental | Participants received a single ascending dose of LXE408 or Placebo (fasted). Receives: Drug: LXE408; Drug: Placebo |
| Part B - Multiple ascending Dose (MAD): Cohort 1: LXE408/Placebo | Experimental | Participants received multiple ascending doses of LXE408 once daily or Placebo. Receives: Drug: LXE408; Drug: Placebo |
| Part B - MAD: Cohort 2: LXE408/Placebo | Experimental | Participants received multiple ascending doses of LXE408 once daily or Placebo. Receives: Drug: LXE408; Drug: Placebo |
| Part B - MAD: Cohort 3: LXE408/Placebo | Experimental | Participants received multiple ascending doses of LXE408 mg once daily or Placebo. Receives: Drug: LXE408; Drug: Placebo |
| Part B - MAD: Cohort 4: LXE408/Placebo | Experimental | Participants received multiple ascending doses of LXE408 once daily or Placebo. Receives: Drug: LXE408; Drug: Placebo |
| Part B - MAD: Cohort 5 (mGFR cohort): LXE408/Placebo | Experimental | Participants in this Measured glomerular filtration rate (mGFR) cohort received multiple ascending doses of LXE408 and iohexol or Placebo and iohexol. Receives: Drug: LXE408; Drug: Placebo; Drug: Iohexol |
| Part B - MAD: Cohort 6: LXE408/Placebo | Experimental | Participants received multiple ascending doses of LXE408 once daily or Placebo. Receives: Drug: LXE408; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Part A: Single Ascending Dose (SAD): 35 days; Part A: SAD (Food Effect): 63 days; Part B: Multiple Ascending Dose (MAD): 45 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start21 Dec 2018
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809919
- Sponsor's protocol ID
- CLXE408X2101
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Subject Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LXE408 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07809919
- Acronym / sponsor ID
- CLXE408X2101
- Conditions
- Visceral Leishmaniasis, Chagas Disease
- Keywords
- LXE408, first-in-human study, Phase l, First-in-human, healthy subject, single ascending dose, multiple ascending dose, visceral leishmaniasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A - Single Ascending Dose (SAD): Cohort 1: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received a single ascending dose of LXE408 or Placebo (fasted). |
| Part A - SAD: Cohort 2: LXE408 /Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received a single ascending dose of LXE408 or Placebo (fasted). |
| Part A - SAD: Cohort 3a/b: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants 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. |
| Part A - SAD: Cohort 4: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received a single ascending dose of LXE408 or Placebo (fasted). |
| Part A - SAD: Cohort 5: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received a single ascending dose of LXE408 or Placebo (fasted). |
| Part B - Multiple ascending Dose (MAD): Cohort 1: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received multiple ascending doses of LXE408 once daily or Placebo. |
| Part B - MAD: Cohort 2: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received multiple ascending doses of LXE408 once daily or Placebo. |
| Part B - MAD: Cohort 3: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received multiple ascending doses of LXE408 mg once daily or Placebo. |
| Part B - MAD: Cohort 4: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received multiple ascending doses of LXE408 once daily or Placebo. |
| Part B - MAD: Cohort 5 (mGFR cohort): LXE408/Placebo | Experimental | Drug: LXE408, Drug: Placebo, Drug: IohexolParticipants in this Measured glomerular filtration rate (mGFR) cohort received multiple ascending doses of LXE408 and iohexol or Placebo and iohexol. |
| Part B - MAD: Cohort 6: LXE408/Placebo | Experimental | Drug: LXE408, Drug: PlaceboParticipants received multiple ascending doses of LXE408 once daily or Placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent must be obtained before any assessment is performed.
- Healthy male and female subjects 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline.
- 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:
- Subjects must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) within the range of 18 - 30 kg/m2. [BMI = Body weight (kg) / [Height (m)]2]
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Key exclusion criteria (22 listed)
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Known history or current clinically significant cardiac arrhythmias.
- Significant illness which has not resolved within two (2) weeks prior to baseline.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
- Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LXE408LXE408 comes in film coated tablets and is taken orally. | Drug | Part A - SAD: Cohort 2: LXE408 /Placebo, Part A - SAD: Cohort 3a/b: LXE408/Placebo, Part A - SAD: Cohort 4: LXE408/Placebo, Part A - SAD: Cohort 5: LXE408/Placebo, Part A - Single Ascending Dose (SAD): Cohort 1: LXE408/Placebo, Part B - MAD: Cohort 2: LXE408/Placebo, Part B - MAD: Cohort 3: LXE408/Placebo, Part B - MAD: Cohort 4: LXE408/Placebo, Part B - MAD: Cohort 5 (mGFR cohort): LXE408/Placebo, Part B - MAD: Cohort 6: LXE408/Placebo, Part B - Multiple ascending Dose (MAD): Cohort 1: LXE408/Placebo |
| PlaceboLXE408 matching placebo comes in film coated tablets and is taken orally. | Drug | Part A - SAD: Cohort 2: LXE408 /Placebo, Part A - SAD: Cohort 3a/b: LXE408/Placebo, Part A - SAD: Cohort 4: LXE408/Placebo, Part A - SAD: Cohort 5: LXE408/Placebo, Part A - Single Ascending Dose (SAD): Cohort 1: LXE408/Placebo, Part B - MAD: Cohort 2: LXE408/Placebo, Part B - MAD: Cohort 3: LXE408/Placebo, Part B - MAD: Cohort 4: LXE408/Placebo, Part B - MAD: Cohort 5 (mGFR cohort): LXE408/Placebo, Part B - MAD: Cohort 6: LXE408/Placebo, Part B - Multiple ascending Dose (MAD): Cohort 1: LXE408/Placebo |
| IohexolIohexol 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. | Drug | Part B - MAD: Cohort 5 (mGFR cohort): LXE408/Placebo |
Primary outcome
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
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
To assess the safety and tolerability of of single and multiple ascending oral doses of LXE408.
10 secondary outcomes
Pharmacokinetics (PK) of LXE408 and its metabolite MAN519: AUC (AUC0-24; AUCtau, AUClast, AUCinf as relevant) Parts A (SAD) & B (MAD)
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
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
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
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
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
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
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
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
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LXE408 and Iohexol in people with Visceral Leishmaniasis and Chagas Disease, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.