Trial Outcomes & Findings for Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants (NCT NCT06190678)

NCT ID: NCT06190678

Last Updated: 2025-01-13

Results Overview

PK: Cmax of pirtobrutinib

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: 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)
• Results posted on: 2025-01-13

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	8	8
Overall Study Received Dose of Pirtobrutinib	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants

Baseline characteristics by cohort

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=8 Participants 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.	Total n=16 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 4.06 • n=5 Participants	64 years STANDARD_DEVIATION 6.93 • n=7 Participants	61.1 years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: Cmax of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Pirtobrutinib	3450 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 19.7	2910 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 30.9

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: Tmax of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib	3 hours Interval 1.5 to 8.0	2 hours Interval 0.75 to 3.0

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: AUC0-t of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib	73800 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 18.6	103000 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 34.2

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: AUC0-inf of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib	75100 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 18.3	107000 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 35.3

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: %AUCextrap of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib	1.55 percentage of AUCextrap Geometric Coefficient of Variation 46.2	4.05 percentage of AUCextrap Geometric Coefficient of Variation 28.3

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: λZ of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib	0.0317 1/hour (1/h) Geometric Coefficient of Variation 22.6	0.0183 1/hour (1/h) Geometric Coefficient of Variation 10.8

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: t½ of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib	21.9 hours Geometric Coefficient of Variation 22.6	37.8 hours Geometric Coefficient of Variation 10.8

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: CL/F of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib	2.66 liter per hour (L/h) Geometric Coefficient of Variation 18.3	1.86 liter per hour (L/h) Geometric Coefficient of Variation 35.3

PRIMARY outcome

Timeframe: 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)

Population: 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.

PK: Vz/F of pirtobrutinib

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Pirtobrutinib	84 Liter (L) Geometric Coefficient of Variation 19.2	102 Liter (L) Geometric Coefficient of Variation 29.4

PRIMARY outcome

Timeframe: 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)

Population: 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.

MRT is the average time a drug molecule stays in the body, calculated from the AUC0-inf.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Mean Residence Time (MRT) of Pirtobrutinib	27.6 hours Geometric Coefficient of Variation 13.3	48.8 hours Geometric Coefficient of Variation 10.4

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Unbound Cmax (Cmax,u) of Pirtobrutinib	131 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 25.5	110 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 26.6

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Unbound AUC0-t (AUC0-t,u) of Pirtobrutinib	2800 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 24.7	3870 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 36.6

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Unbound AUC0-inf (AUC0-inf,u) of Pirtobrutinib	2850 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 24.8	4040 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 37.4

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Unbound CL/F (CL/F,u) of Pirtobrutinib	70.2 liter per hour (L/h) Geometric Coefficient of Variation 24.8	49.5 liter per hour (L/h) Geometric Coefficient of Variation 37.4

PRIMARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Pirtobrutinib (Normal Renal Function) n=8 Participants 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.	Pirtobrutinib (Severe Renal Impairment) n=7 Participants 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.
PK: Unbound Vz/F (Vz/F,u) of Pirtobrutinib	2210 Liter (L) Geometric Coefficient of Variation 16.8	2700 Liter (L) Geometric Coefficient of Variation 35.2

Adverse Events

Pirtobrutinib (Normal Renal Function)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pirtobrutinib (Severe Renal Impairment)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pirtobrutinib (Normal Renal Function) n=8 participants at risk 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.	Pirtobrutinib (Severe Renal Impairment) n=8 participants at risk 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.	25.0% 2/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.	12.5% 1/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.
Infections and infestations Cellulitis	0.00% 0/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.	12.5% 1/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.
Vascular disorders Thrombophlebitis	0.00% 0/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.	12.5% 1/8 • Baseline to Follow-up (Up To Day 17) All participants who received a dose of Pirtobrutinib.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800- 545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60