Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632600
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Study of Efficacy Safety Tolerability of LXE408 in Participants With Chronic Chagas Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Participant- and Investigator-blinded Controlled Parallel Group Study to Assess the Efficacy Safety Tolerability Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease Participants must have chronic Chagas disease without severe organ dysfunction
Detailed Description:
This is interventional phase 2 PoC Proof of Concept randomized participant- and investigator-blinded controlled parallel group study with 4 treatment arms The purpose of this study is to assess the efficacy anti-parasitological activity safety PK pharmacokinetics and PD pharmacodynamics of LXE408 in participants with CICD chronic indeterminate Chagas disease and chronic CD chronic Chagas disease without severe cardiac or gastrointestinal dysfunction compared to placebo and to benznidazole
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None