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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNG | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired kidney function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last around 46 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib (Normal Renal Function) | Experimental | Participants with normal renal function (eGFR >= 90 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1. |
|
| Pirtobrutinib (Severe Renal Impairment) | Experimental | Participants with severe renal impairment (eGFR: < 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib | 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) |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib | 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) |
| 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 | 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) |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of pirtobrutinib | 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) |
| PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib | 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) |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib | PK: λZ of pirtobrutinib | 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) |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
Participants with out-of-range, at-rest vital signs.
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
Receipt of blood products within 2 months prior to Check-in (Day -1).
Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
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| Name | Affiliation | Role |
|---|---|---|
| Renée Ward, MD, PhD | Loxo Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Institute | Anaheim | California | 92801 | United States | ||
| Riverside Clinical Research |
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Participants with normal renal function, as well as those with mild, moderate, or severe renal impairment, were initially planned to be enrolled in the study. However, based on the results of the interim analysis, it was decided that including participants with mild or moderate renal impairment was not required.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pirtobrutinib (Normal Renal Function) | Participants with normal renal function (eGFR: >= 90 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
| FG001 | Pirtobrutinib (Severe Renal Impairment) | Participants with severe renal impairment (eGFR: < 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pirtobrutinib (Normal Renal Function) | Participants with normal renal function (eGFR: >= 90 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
| BG001 | Pirtobrutinib (Severe Renal Impairment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) |
|
Baseline to Follow-up (Up To Day 17)
All participants who received a dose of Pirtobrutinib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pirtobrutinib (Normal Renal Function) | Participants with normal renal function (eGFR: >= 90 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800- 545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2021 | Oct 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2021 | Oct 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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| PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | PK: t½ of pirtobrutinib | 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) |
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of pirtobrutinib | 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) |
| PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of pirtobrutinib | 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) |
| PK: Mean Residence Time (MRT) of Pirtobrutinib | MRT is the average time a drug molecule stays in the body, calculated from the AUC0-inf. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| Edgewater |
| Florida |
| 32132 |
| United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
Participants with severe renal impairment (eGFR: < 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| Pirtobrutinib (Severe Renal Impairment) |
Participants with severe renal impairment (eGFR: < 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. |
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| Primary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib | PK: λZ 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 | 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) |
|
|
|
| Primary | PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | PK: 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 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) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Pirtobrutinib (Severe Renal Impairment) | Participants with severe renal impairment (eGFR: < 30 mL/min/1.73 m2) received a single dose of Pirtobrutinib 200 mg administered orally on Day 1. | 0 | 8 | 0 | 8 | 3 | 8 |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |