| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to 24 Hours Post-Dose (AUC0-24): Caffeine | Area under the concentration time curve (AUC) from hour 0 to 24 hours post-dose (AUC0-24) of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00039100± 31.8
- OG00137400± 31.8
|
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| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to 24 Hours Post-Dose (AUC0-24): Paraxanthine | AUC0-24 of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to 24 Hours Post-Dose (AUC0-24): Omeprazole | AUC0-24 of Omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to 24 Hours Post-Dose (AUC0-24): Warfarin | AUC(0-24) of Warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to 24 Hours Post-Dose (AUC0-24): Pirtobrutinib | AUC0-24 of Pirtobrutinib was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 2, Day 15 (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post dose) | | | | ID | Title | Description |
|---|
| OG000 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration-time Curve (AUC), From Hour 0 to the Last Measurable Concentration (AUC0-t): Caffeine | AUC from hour 0 to the last measurable concentration (AUC0-t) of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration-time Curve (AUC), From Hour 0 to the Last Measurable Concentration (AUC0-t): Paraxanthine | AUC0-t of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t): Omeprazole | AUC0-t of Omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t): Warfarin | AUC0-t of Warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In Period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t): Pirtobrutinib | AUC0-t of Pirtobrutinib was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 2, Day 15 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 Extrapolated to Infinity (AUC0-inf): Caffeine | AUC from hour 0 extrapolated to infinity (AUC0-inf) of Caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 Extrapolated to Infinity (AUC0-inf): Paraxanthine | AUC0-inf of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 Extrapolated to Infinity (AUC0-inf): Omeprazole | AUC0-inf of omeprazole was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Area Under the Concentration Time Curve (AUC) From Hour 0 Extrapolated to Infinity (AUC0-inf): Warfarin | AUC0-inf of Warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Percentage Extrapolation for AUC0-inf (%AUCextrap): Caffeine | AUC0-inf (%AUCextrap) of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Percentage Extrapolation for AUC0-inf (%AUCextrap): Paraxanthine | AUC0-inf (%AUCextrap) of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Percentage Extrapolation for AUC0-inf (%AUCextrap): Omeprazole | %AUCextrap of omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Percentage Extrapolation for AUC0-inf (%AUCextrap): Warfarin | %AUCextrap of Warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Apparent Systemic Clearance (CL/F): Caffeine | CL/F for caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Apparent Systemic Clearance (CL/F): Omeprazole | CL/F of omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
| |
| Primary | Apparent Systemic Clearance (CL/F): Warfarin | CL/F of warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Systemic Clearance (CL/F): Pirtobrutinib | CL/F of Pirtobrutinib was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Period 2, Day 15 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose) | | | | ID | Title | Description |
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| OG000 | Pirtobrutinib 200 mg QD + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Maximum Observed Plasma Concentration (Cmax): Caffeine | Cmax of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Maximum Observed Plasma Concentration (Cmax): Paraxanthine | Cmax of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Maximum Observed Plasma Concentration (Cmax): Omeprazole | Cmax of omeprazole was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Maximum Observed Plasma Concentration (Cmax): Warfarin | Cmax of warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Maximum Observed Plasma Concentration (Cmax): Pirtobrutinib | Cmax of Pirtobrutinib was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Period 2, Day 15 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax): Caffeine | Tmax of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Median | Full Range | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax): Paraxanthine | Tmax of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Median | Full Range | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax): Omeprazole | Tmax of omeprazole was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Median | Full Range | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax): Warfarin | Tmax of warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Median | Full Range | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax): Pirtobrutinib | Tmax of Pirtobrutinib was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Median | Full Range | hour (h) | | Period 2, Day 15 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Rate Constant (λZ): Caffeine | λZ of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Least Squares Mean | Geometric Coefficient of Variation | 1/hour (1/h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Rate Constant (λZ): Paraxanthine | λZ of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Rate Constant (λZ): Omeprazole | λZ of omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Rate Constant (λZ): Warfarin | λZ of warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Volume of Distribution at Terminal Phase (Vz/F): Caffeine | Vz/F of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litre (L) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Volume of Distribution at Terminal Phase (Vz/F): Omeprazole | Vz/F of omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litre (L) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Volume of Distribution at Terminal Phase (Vz/F): Warfarin | Vz/F of Warfarin was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litre (L) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Metabolite to Parent Drug AUC Ratio (MRAUC): AUC Ratio of Paraxanthine to Caffeine | AUC Ratio of paraxanthine (Metabolite) to caffeine (Parent drug) was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Mean Residence Time (MRT): Caffeine | MRT of caffeine was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Mean Residence Time (MRT): Paraxanthine | MRT of Paraxanthine was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Mean Residence Time (MRT): Omeprazole | MRT of omeprazole was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Mean Residence Time (MRT): Warfarin | MRT of warfarin was reported. | All participants who received a dose of study drug had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Half-Life (t1/2): Caffeine | t1/2 of caffeine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Half-Life (t1/2): Paraxanthine | t1/2 of Paraxanthine was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Half-Life (t1/2): Omeprazole | t1/2 of omeprazole was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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| Primary | Apparent Terminal Elimination Half-Life (t1/2): Warfarin | t1/2 of warfarin was reported. | All participants who received a dose of study drug, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter could be computed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (h) | | Period 1, Day 1 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose); Period 2, Day 15 (Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose) | | | | ID | Title | Description |
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| OG000 | Period 1: Probe Drug Cocktail | In period 1, 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. | | OG001 | Period 2: Pirtobrutinib + Probe Drug Cocktail | In Period 2, 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. |
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