Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sitamaquine · 1 trial · 1 indication
AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Only those participants with data available at the specified time points were analyzed.
Cmax was defined as the maximum concentration of sitamaquine. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Tmax is defined as the time to peak concentration from initiation of sitamaquine dosing. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21.
Point estimate was the ratio of adjusted geometric means between repeat dosing days (Day 21 or Day 10) and single dose day (Day 1). An evaluation on the accumulation rate was based upon the comparison of AUC(0-24) values after repeated dosing to the values from the first dose on day 1. Blood samples for determination of plasma concentrations of sitamaquine was obtained at the following time points on days 1, 10 and 21: immediately pre-dose, and at 1, 2, 3, 4, 6, 10, 16 hours post dose. An additional sample was taken on Day 23 and Day 24 to approximate 48 hours and 72 hours post last dose on Day 21. Individual observed accumulation ratios on Day 10 were calculated by dividing AUC (0-tau) on Day 10 by AUC (0-tau) on Day 1. A similar formula was applied to the accumulation ratio on Day 21.
| Name | Type | Description |
|---|---|---|
| sitamaquine | DRUG | - |
Inclusion criteria: * Clinical diagnosis of visceral leishmaniasis; symptoms and signs compatible with VL and diagnosis confirmed by visualisation of amastigotes in splenic aspirate or bone marrow. * Written informed consent or witnessed oral consent. * Willing to comply with the study visits and p...
Sitamaquine is an investigational small molecule being studied for the treatment of visceral leishmaniasis, a serious parasitic infection. It is being developed by GSK plc (GSK) and has completed a Phase 2 clinical trial in India.
Sitamaquine is a small molecule, but its specific molecular target has not been disclosed in available information. It is being evaluated for its potential to treat visceral leishmaniasis, a disease caused by Leishmania parasites.
Sitamaquine is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in clinical development for visceral leishmaniasis.
Sitamaquine is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug, not yet approved by regulatory authorities.
Sitamaquine has been studied in a completed Phase 2 trial with the identifier NCT00381394. This trial enrolled 61 participants in India and compared sitamaquine with amphotericin B for the treatment of visceral leishmaniasis.
No, sitamaquine is not the same as amphotericin B. In a clinical trial, sitamaquine was compared with amphotericin B, which is an existing antifungal and antiparasitic drug used as a standard treatment for visceral leishmaniasis.