| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06215430 | A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Jan 11, 2021 | Apr 15, 2021 | Mar 10, 2025 | 1 | United States |
Area under the concentration time curve (AUC) from hour 0 to 24 hours post-dose (AUC0-24) of caffeine was reported.
AUC0-24 of Paraxanthine was reported.
AUC0-24 of Omeprazole was reported.
AUC(0-24) of Warfarin was reported.
AUC0-24 of Pirtobrutinib was reported.
AUC from hour 0 to the last measurable concentration (AUC0-t) of caffeine was reported.
AUC0-t of Paraxanthine was reported.
AUC0-t of Omeprazole was reported.
AUC0-t of Warfarin was reported.
AUC0-t of Pirtobrutinib was reported.
AUC from hour 0 extrapolated to infinity (AUC0-inf) of Caffeine was reported.
AUC0-inf of Paraxanthine was reported.
AUC0-inf of omeprazole was reported.
AUC0-inf of Warfarin was reported.
AUC0-inf (%AUCextrap) of caffeine was reported.
AUC0-inf (%AUCextrap) of Paraxanthine was reported.
%AUCextrap of omeprazole was reported.
%AUCextrap of Warfarin was reported.
CL/F for caffeine was reported.
CL/F of omeprazole was reported.
CL/F of warfarin was reported.
CL/F of Pirtobrutinib was reported.
Cmax of caffeine was reported.
Cmax of Paraxanthine was reported.
Cmax of omeprazole was reported.
Cmax of warfarin was reported.
Cmax of Pirtobrutinib was reported.
Tmax of caffeine was reported.
Tmax of Paraxanthine was reported.
Tmax of omeprazole was reported.
Tmax of warfarin was reported.
Tmax of Pirtobrutinib was reported.
λZ of caffeine was reported.
λZ of Paraxanthine was reported.
λZ of omeprazole was reported.
λZ of warfarin was reported.
Vz/F of caffeine was reported.
Vz/F of omeprazole was reported.
Vz/F of Warfarin was reported.
AUC Ratio of paraxanthine (Metabolite) to caffeine (Parent drug) was reported.
MRT of caffeine was reported.
MRT of Paraxanthine was reported.
MRT of omeprazole was reported.
MRT of warfarin was reported.
t1/2 of caffeine was reported.
t1/2 of Paraxanthine was reported.
t1/2 of omeprazole was reported.
t1/2 of warfarin was reported.
| Arm | Type | Description |
|---|---|---|
| Period 1: Probe Drug Cocktail | EXPERIMENTAL | Participants received 200 milligrams (mg) caffeine tablet, 40 mg omeprazole capsule, and 10 mg warfarin tablet as a single dose of probe drug cocktail, along with 10 mg vitamin K tablet on Day 1. |
| Period 2: Pirtobrutinib + Probe Drug Cocktail | EXPERIMENTAL | Participants received oral dose of 200 mg Pirtobrutinib once daily (QD) from Day 6 to Day 19. On Day 15, Pirtobrutinib was co-administered with 200 mg caffeine tablet, 40 mg omeprazole capsule, and 10 mg warfarin tablet as a single dose of probe drug cocktail, along with 10 mg vitamin K tablet. There was a 5-day washout period between the probe drug cocktail on Day 1 (Period 1) and the first dose of Pirtobrutinib on Day 6 (Period 2). |
| Name | Type | Description |
|---|---|---|
| Caffeine Tablet | DRUG | Administered orally. |
| Omeprazole capsule | DRUG | Administered orally. |
| Warfarin tablet | DRUG | Administered orally. |
| Pirtobrutinib | DRUG | Administered orally. |
Inclusion Criteria: * Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive. * Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign m...