Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Danirixin HBr IR · 1 trial · 1 indication
Danirixin PK parameters area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-inf\]) and maximum observed concentration (Cmax) following single dose administration of FB tablet (reference), relative to HBr tablet (test) will be assessed.
AE/SAE will be collected from the start of study treatment and until the follow-up visit or contact for study treatment period 5. Intensity of AEs will be categorized as mild, moderate or severe. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity is a congenital anomaly/birth defect is associated with liver injury and impaired liver function.
Vital signs will include temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate.
ECG will be obtained at selected time-points during the study.
Clinical laboratory tests will include hematology, clinical chemistry and urinalysis.
| Arm | Type | Description |
|---|---|---|
| Danirixin HBr + Danirixin FB + Omeprazole | EXPERIMENTAL | Subjects will receive danirixin FB 50 milligram (mg) immediate release (IR) tablet, single dose, in the fed state (treatment A), danirixin HBr 50 mg IR tablet, single dose, in the fed state (treatment B), danirixin HBr 50 mg IR tablet, single dose, in the fasted state (treatment C), or danirixin HBr 50 mg IR tablet, single dose, in the fed state (treatment D) as per randomization in period 1 to 4. In treatment Period 5, subjects will receive danirixin HBr 50 mg IR table, single dose, in the fed state with concomitant, steady state OMP (40 mg once daily for 5 days) (treatment E). Subject will receive treatment with washout period of 5 days in one of the four sequence DCABE, ADBCE, BACDE, CBDAE. |
| Name | Type | Description |
|---|---|---|
| Danirixin HBr 50 mg IR Tablet | DRUG | Danirixin HBr 50 mg IR Tablet is white, film-coated, oval-shaped tablet for oral administration. |
| Danirixin FB 50 mg IR Tablet | DRUG | Danirixin FB 50 mg IR Tablet is white, film-coated, capsule-shaped tablet for oral administration. |
| Prilosec (omeprazole) 40mg Delayed-Release capsule | DRUG | Prilosec (omeprazole) 40 mg delayed-release capsule is opaque, hard gelatin, apricot, and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body for oral administration. |
Inclusion Criteria: * Between 65 and 80 years of age at screening (inclusive) * Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring or a subject with a clinical abno...
Danirixin HBr IR is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential role in managing this respiratory condition.
Danirixin HBr IR is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in healthy elderly subjects.
Danirixin HBr IR is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing development program includes a completed Phase 1 study that assessed the bioavailability and food effects of different oral formulations of the drug.
Danirixin HBr IR has one completed Phase 1 clinical trial registered under NCT02453022. This study enrolled 18 healthy elderly subjects in the United States and evaluated the relative bioavailability and food effect of two oral formulations of GSK1325756, including the HBr salt form, when given with omeprazole.
Danirixin HBr IR is a formulation of the investigational drug GSK1325756. The HBr salt form is one of the oral formulations being studied in clinical trials. The completed Phase 1 study compared the free base and HBr salt formulations of GSK1325756 to assess their bioavailability and food effects.