Approval Probability
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Adjusted LOA
ML Risk
Levocetirizine IRT · 1 trial · 1 indication
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
| Arm | Type | Description |
|---|---|---|
| Subjects of Group A: Part 1 | EXPERIMENTAL | Subjects in Group A will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 2. |
| Subjects of Group B: Part 1 | EXPERIMENTAL | Subjects in Group B will be randomized to receive levocetirizine ODT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
| Subjects of Group C: Part 2 | EXPERIMENTAL | Subjects in Group C will be randomized to receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine ODT 5 mg without water in fasted state in Period 2. |
| Subjects of Group D: Part 2 | EXPERIMENTAL | Subjects in Group D will be randomized to receive levocetirizine ODT 5 mg without water in fasted state in Period 1. After a washout period of at least 5 days, subjects will receive levocetirizine IRT 5 mg with 150 mL water in fasted state in Period 2. |
| Name | Type | Description |
|---|---|---|
| Levocetirizine IRT 5 mg | DRUG | Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2). |
| Levocetirizine ODT 5 mg | DRUG | Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water. |
Inclusion Criteria: * Subjects must be 20 to 55 years of age inclusive, at the time of signing the informed consent. * Japanese subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Subjects ...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Levocetirizine IRT is an immediate release tablet formulation of levocetirizine, a small molecule drug being developed by GSK plc for rhinitis. It is an investigational product in Phase 1 clinical development. Levocetirizine IRT is also known as Levocetirizine IRT 5 mg.
Levocetirizine IRT is being developed for the treatment of rhinitis. The clinical program lists rhinitis as the condition under study. It is an investigational formulation and has not been established as an approved treatment based on the available development information.
Levocetirizine IRT targets HRH1, the histamine H1 receptor, and acts as an antagonist at this receptor. By blocking HRH1, the drug is designed to interfere with histamine signaling, which is relevant to allergic conditions such as rhinitis.
Levocetirizine IRT is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the clinical development program for this immediate release tablet formulation of levocetirizine.
Levocetirizine IRT is in Phase 1 clinical development. It is an investigational drug and is not described as FDA approved. The development program includes one completed Phase 1 trial, and no active trials are currently listed for this asset.
Levocetirizine IRT has been studied in one completed Phase 1 trial, NCT03555890, titled a bioequivalence study between levocetirizine oral disintegrating tablet and levocetirizine immediate release tablet. The trial enrolled 72 healthy male volunteers in Japan, was randomized and controlled, and did not use blinding.