| Primary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 | Pirtobrutinib (Severe Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0004240± 32.4
- OG0014410± 22.7
- OG0024140± 20.8
- OG003
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| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Median | Full Range | hours | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 | Pirtobrutinib (Severe Hepatic Impairment) |
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC0-t of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | |
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 |
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| Primary | PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 |
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| Primary | PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 | Pirtobrutinib (Severe Hepatic Impairment) |
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| Primary | PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 | Pirtobrutinib (Severe Hepatic Impairment) |
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| Primary | PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of pirtobrutinib | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 |
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| Primary | PK: Mean Residence Time (MRT) of Pirtobrutinib | MRT is the average time a drug molecule stays in the body, calculated from the AUC0-inf. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG003 |
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| Primary | PK: Unbound Cmax (Cmax,u) of Pirtobrutinib | Cmax,u was calculated by multiplying Cmax by Fu (i.e., Cmax*Fu). Fu represents the unbound fraction, which is the portion of the drug in the bloodstream that is unbound to plasma proteins. It is expressed as a decimal and will be calculated from protein binding concentration data as the unbound drug concentration divided by the total drug concentration in plasma. The concentrations of total and unbound drug were determined in a sample of predose plasma fortified with a known concentration of drug. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | |
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| Primary | PK: Unbound AUC0-t (AUC0-t,u) of Pirtobrutinib | AUC0-t,u was calculated by multiplying AUC0-t by Fu (i.e., AUC0-t*Fu). Fu represents the unbound fraction, which is the portion of the drug in the bloodstream that is unbound to plasma proteins. It is expressed as a decimal and will be calculated from protein binding concentration data as the unbound drug concentration divided by the total drug concentration in plasma. The concentrations of total and unbound drug were determined in a sample of predose plasma fortified with a known concentration of drug. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | |
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| Primary | PK: Unbound AUC0-inf (AUC0-inf,u) of Pirtobrutinib | AUC0-inf,u was calculated by multiplying AUC0-inf by Fu (i.e., AUC0-inf*Fu). Fu represents the unbound fraction, which is the portion of the drug in the bloodstream that is unbound to plasma proteins. It is expressed as a decimal and will be calculated from protein binding concentration data as the unbound drug concentration divided by the total drug concentration in plasma. The concentrations of total and unbound drug were determined in a sample of predose plasma fortified with a known concentration of drug. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | |
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| Primary | PK: Unbound CL/F (CL/F,u) of Pirtobrutinib | CL/F,u was calculated by multiplying CL/F by Fu (i.e., CL/F*Fu). Fu represents the unbound fraction, which is the portion of the drug in the bloodstream that is unbound to plasma proteins. It is expressed as a decimal and will be calculated from protein binding concentration data as the unbound drug concentration divided by the total drug concentration in plasma. The concentrations of total and unbound drug were determined in a sample of predose plasma fortified with a known concentration of drug. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 |
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| Primary | PK: Unbound Vz/F (Vz/F,u) of Pirtobrutinib | Vz/F,u was calculated by multiplying Vz/F by Fu (i.e., Vz/F*Fu). Fu represents the unbound fraction, which is the portion of the drug in the bloodstream that is unbound to plasma proteins. It is expressed as a decimal and will be calculated from protein binding concentration data as the unbound drug concentration divided by the total drug concentration in plasma. The concentrations of total and unbound drug were determined in a sample of predose plasma fortified with a known concentration of drug. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | | OG001 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. | | OG002 |
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| Primary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Normal Hepatic Function) | | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Number | | 1/hour (1/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Normal Hepatic Function) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
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| Primary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Mild Hepatic Function) | | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Number | | 1/hour (1/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Mild Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. |
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| Primary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Moderate Hepatic Function) | | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Number | | 1/hour (1/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Moderate Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
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| Primary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Severe Hepatic Function) | | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable plasma concentration of Pirtobrutinib and had at least 1 PK parameter computed. Subjects were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax. | Posted | | Number | | 1/hour (1/h) | | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Pirtobrutinib (Severe Hepatic Impairment) | Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
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