Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02453022 | A 5-Period, Single Dose, Phase 1 Study in Healthy Elderly Subjects to Assess Relative Bioavailability and Food Effect of Two Oral Formulations of GSK1325756 (Free Base vs HBr Salt) and Food Effect on the HBr Formulation When Given With Omeprazole | PHASE1 | COMPLETED | 18 | — | — | May 18, 2015 | Jul 31, 2015 | Jul 24, 2018 | 1 | United States |
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...