Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nifurtimox _Test · 1 trial · 1 indication
AUC:area under the concentration versus time curve from zero to infinity after single (first) dose
AUC(0-tlast): AUC from time 0 to the last data point \> LLOQ(lower limit of quantitation)
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
| Arm | Type | Description |
|---|---|---|
| Test Treatment + Reference Treatment | EXPERIMENTAL | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Test treatment 2. Reference treatment |
| Reference Treatment + Test Treatment | EXPERIMENTAL | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Reference treatment 2. Test treatment |
| Name | Type | Description |
|---|---|---|
| Nifurtimox (Lampit, BAYA2502)_Test | DRUG | Orally intake of 1 \*120mg new formulation tablet as test treatment |
| Nifurtimox (Lampit, BAYA2502)_Reference | DRUG | Orally intake of 1 \*120mg current clinical formulation tablet as reference treatment |
Inclusion Criteria: \- Male/female patient diagnosed with chronic Chagas' disease: Previous diagnosis of acute or chronic Chagas' disease by a health clinic prior to screening for the study. The diagnosis of chronic Chagas' disease may be made by clinical findings, supported by antibody titers if a...
Nifurtimox _Test is an investigational small molecule developed by Bayer AG. It is being studied in a Phase 1 clinical program, with one completed trial evaluating a new oral tablet formulation. The specific therapeutic indication for this asset has not been disclosed.
Nifurtimox _Test is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program for this asset.
Nifurtimox _Test is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA.
Nifurtimox _Test has been evaluated in one completed Phase 1 trial, NCT03708133, titled "Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation." The trial enrolled 24 participants in Argentina and used a controlled, randomized design without double blinding.
Yes, Nifurtimox _Test is also known as Nifurtimox, Lampit, and BAYA2502. These names refer to the same asset developed by Bayer AG under ticker BAYRY.