Trial Outcomes & Findings for Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK (NCT NCT04546789)

NCT ID: NCT04546789

Last Updated: 2025-10-28

Results Overview

AUC0-inf was calculated by combining AUC0-tlast and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose
• Results posted on: 2025-10-28

Participant Flow

A total of 32 participants were screened. Out of which, 24 participants were enrolled and treated in the study.

Participant milestones

Measure	Group 1: Normal Hepatic Function (Reference) Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK

Baseline characteristics by cohort

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Total n=24 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 5.70 • n=5 Participants	58.4 years STANDARD_DEVIATION 11.30 • n=7 Participants	58.9 years STANDARD_DEVIATION 10.40 • n=5 Participants	60.8 years STANDARD_DEVIATION 9.60 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The Pharmacokinetic Analysis Population (PK) was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active Investigational Medicinal Product (IMP) and provide at least one measurable post-dose concentration. A measurement below lower limit of quantification (BLQ) is considered a valid measurement.

AUC0-inf was calculated by combining AUC0-tlast and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M2951	186 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 23.6	232 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 60.6	362 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 21.8

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLOQ is considered a valid measurement.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Maximum Observed Plasma Concentration (Cmax) of M2951	63.8 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 14.2	79.2 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 86.2	118 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 29.9

SECONDARY outcome

Timeframe: up to follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that started or worsened that in severity after at least one dose of the study intervention has been administered. TEAEs included both serious TEAEs and non-serious TEAEs.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes. Change from baseline in hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, and reticulocytes at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Basophils: Day 2	-0.006 10^9 cells per liter Standard Deviation 0.0160	-0.005 10^9 cells per liter Standard Deviation 0.0107	-0.003 10^9 cells per liter Standard Deviation 0.0175
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Basophils: follow- up (Day 6)	-0.003 10^9 cells per liter Standard Deviation 0.0128	0.004 10^9 cells per liter Standard Deviation 0.0119	0.006 10^9 cells per liter Standard Deviation 0.0119
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Eosinophils: Day 2	-0.007 10^9 cells per liter Standard Deviation 0.0984	-0.025 10^9 cells per liter Standard Deviation 0.0568	0.010 10^9 cells per liter Standard Deviation 0.0650
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Eosinophils: follow- up (Day 6)	0.000 10^9 cells per liter Standard Deviation 0.0626	-0.040 10^9 cells per liter Standard Deviation 0.0518	0.016 10^9 cells per liter Standard Deviation 0.1051
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Leukocytes: Day 2	0.54 10^9 cells per liter Standard Deviation 0.597	-0.28 10^9 cells per liter Standard Deviation 0.504	-0.68 10^9 cells per liter Standard Deviation 1.074
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Leukocytes: follow- up (Day 6)	0.11 10^9 cells per liter Standard Deviation 0.751	-0.10 10^9 cells per liter Standard Deviation 0.857	-0.66 10^9 cells per liter Standard Deviation 1.265
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Lymphocytes: Day 2	0.233 10^9 cells per liter Standard Deviation 0.3186	-0.055 10^9 cells per liter Standard Deviation 0.1099	0.141 10^9 cells per liter Standard Deviation 0.3541
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Lymphocytes: follow- up (Day 6)	0.146 10^9 cells per liter Standard Deviation 0.3074	0.046 10^9 cells per liter Standard Deviation 0.1994	0.024 10^9 cells per liter Standard Deviation 0.2900
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Monocytes: Day 2	0.004 10^9 cells per liter Standard Deviation 0.0752	0.009 10^9 cells per liter Standard Deviation 0.0930	-0.076 10^9 cells per liter Standard Deviation 0.1905
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Monocytes: follow- up (Day 6)	0.008 10^9 cells per liter Standard Deviation 0.0761	0.071 10^9 cells per liter Standard Deviation 0.1173	-0.033 10^9 cells per liter Standard Deviation 0.1618
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Neutrophils: Day 2	0.300 10^9 cells per liter Standard Deviation 0.4459	-0.186 10^9 cells per liter Standard Deviation 0.4348	-0.744 10^9 cells per liter Standard Deviation 0.9999
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Neutrophils: follow- up (Day 6)	-0.043 10^9 cells per liter Standard Deviation 0.8141	-0.169 10^9 cells per liter Standard Deviation 0.7111	-0.659 10^9 cells per liter Standard Deviation 1.1235
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Platelets: Day 2	-3.3 10^9 cells per liter Standard Deviation 21.12	-16.5 10^9 cells per liter Standard Deviation 13.72	-27.3 10^9 cells per liter Standard Deviation 18.73
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Platelets: follow- up (Day 6)	-7.0 10^9 cells per liter Standard Deviation 21.85	-12.0 10^9 cells per liter Standard Deviation 9.80	-22.3 10^9 cells per liter Standard Deviation 23.89
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Reticulocytes: Day 2	3.50 10^9 cells per liter Standard Deviation 5.025	-1.97 10^9 cells per liter Standard Deviation 9.358	-5.01 10^9 cells per liter Standard Deviation 7.052
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets and Reticulocytes Reticulocytes: follow- up (Day 6)	2.51 10^9 cells per liter Standard Deviation 7.248	-3.14 10^9 cells per liter Standard Deviation 4.541	4.76 10^9 cells per liter Standard Deviation 10.136

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameters: basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes and reticulocytes/erythrocytes. Change From Baseline in hematology parameters: basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes and reticulocytes/erythrocytes at Day 2 and Day 6 were reported in percentage.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Basophils/Leukocytes: Day 2	-0.16 percentage of cells Standard Deviation 0.185	-0.04 percentage of cells Standard Deviation 0.207	0.01 percentage of cells Standard Deviation 0.323
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Basophils/Leukocytes: follow- up (Day 6)	-0.08 percentage of cells Standard Deviation 0.212	0.06 percentage of cells Standard Deviation 0.283	0.21 percentage of cells Standard Deviation 0.348
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Eosinophils/Leukocytes: Day 2	-0.33 percentage of cells Standard Deviation 1.285	-0.29 percentage of cells Standard Deviation 0.933	0.31 percentage of cells Standard Deviation 1.249
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Eosinophils/Leukocytes: follow- up (Day 6)	-0.04 percentage of cells Standard Deviation 0.924	-0.45 percentage of cells Standard Deviation 0.802	0.50 percentage of cells Standard Deviation 1.379
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Lymphocytes/Leukocytes: Day 2	0.95 percentage of cells Standard Deviation 3.575	-0.18 percentage of cells Standard Deviation 1.689	3.66 percentage of cells Standard Deviation 6.029
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Lymphocytes/Leukocytes: follow- up (Day 6)	1.49 percentage of cells Standard Deviation 6.414	1.25 percentage of cells Standard Deviation 2.968	2.26 percentage of cells Standard Deviation 4.562
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Monocytes/Leukocytes: Day 2	-0.59 percentage of cells Standard Deviation 1.034	0.39 percentage of cells Standard Deviation 1.578	0.04 percentage of cells Standard Deviation 1.550
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Monocytes/Leukocytes: follow- up (Day 6)	-0.11 percentage of cells Standard Deviation 0.989	1.33 percentage of cells Standard Deviation 1.433	0.56 percentage of cells Standard Deviation 2.042
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Neutrophils/Leukocytes: Day 2	0.12 percentage of cells Standard Deviation 4.556	0.11 percentage of cells Standard Deviation 3.328	-4.02 percentage of cells Standard Deviation 6.968
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Neutrophils/Leukocytes: follow- up (Day 6)	-1.26 percentage of cells Standard Deviation 7.166	-2.19 percentage of cells Standard Deviation 4.008	-3.54 percentage of cells Standard Deviation 7.499
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Reticulocytes/Erythrocyte: Day 2	0.076 percentage of cells Standard Deviation 0.1131	0.008 percentage of cells Standard Deviation 0.1978	-0.083 percentage of cells Standard Deviation 0.1581
Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes and Reticulocytes/Erythrocytes Reticulocytes/Erythrocyte: follow- up (Day 6)	0.085 percentage of cells Standard Deviation 0.1640	0.006 percentage of cells Standard Deviation 0.1314	0.210 percentage of cells Standard Deviation 0.3447

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 2	-0.04 picogram Standard Deviation 0.307	-0.25 picogram Standard Deviation 0.389	-0.07 picogram Standard Deviation 0.373
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Follow- up (Day 6)	-0.09 picogram Standard Deviation 0.348	-0.02 picogram Standard Deviation 0.225	0.06 picogram Standard Deviation 0.487

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume Day 2	0.14 femtoliters Standard Deviation 0.983	0.03 femtoliters Standard Deviation 1.562	-0.22 femtoliters Standard Deviation 1.445
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume Follow- up (Day 6)	0.61 femtoliters Standard Deviation 0.969	0.54 femtoliters Standard Deviation 0.940	-0.19 femtoliters Standard Deviation 0.662

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameters: erythrocytes. Change from baseline in hematology parameters: erythrocytes at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Erythrocytes Day 2	0.017 10^12 cells per liter Standard Deviation 0.1945	-0.096 10^12 cells per liter Standard Deviation 0.2894	-0.113 10^12 cells per liter Standard Deviation 0.2858
Change From Baseline in Hematology Parameter: Erythrocytes Follow- up (Day 6)	-0.083 10^12 cells per liter Standard Deviation 0.1348	-0.163 10^12 cells per liter Standard Deviation 0.1992	-0.179 10^12 cells per liter Standard Deviation 0.1787

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: hematocrit. Change from baseline in hematology parameter: hematocrit at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Hematocrit Day 2	0.0022 liter of cells per liter of blood (L/L) Standard Deviation 0.01795	-0.0096 liter of cells per liter of blood (L/L) Standard Deviation 0.02650	-0.0112 liter of cells per liter of blood (L/L) Standard Deviation 0.03179
Change From Baseline in Hematology Parameter: Hematocrit Follow- up (Day 6)	-0.0042 liter of cells per liter of blood (L/L) Standard Deviation 0.01059	-0.0131 liter of cells per liter of blood (L/L) Standard Deviation 0.01840	-0.0174 liter of cells per liter of blood (L/L) Standard Deviation 0.01683

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: hemoglobin. Change from baseline in hematology parameter: hemoglobin at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Hemoglobin Day 2	0.4 gram per liter (g/L) Standard Deviation 5.55	-4.5 gram per liter (g/L) Standard Deviation 10.43	-3.6 gram per liter (g/L) Standard Deviation 9.23
Change From Baseline in Hematology Parameter: Hemoglobin Follow- up (Day 6)	-2.9 gram per liter (g/L) Standard Deviation 3.94	-5.6 gram per liter (g/L) Standard Deviation 6.82	-5.4 gram per liter (g/L) Standard Deviation 4.44

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: Prothrombin International Normalized Ratio. International Normalized Ratio (INR) is calculated based on the prothrombin time (PT) test results. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system being used. Change from baseline in hematology parameter: prothrombin international normalized ratio at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio Day 2	-0.006 ratio Standard Deviation 0.0160	0.006 ratio Standard Deviation 0.0262	0.006 ratio Standard Deviation 0.0421
Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio Follow- up (Day 6)	0.021 ratio Standard Deviation 0.0295	-0.006 ratio Standard Deviation 0.0580	-0.029 ratio Standard Deviation 0.0391

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the hematology parameter: prothrombin time. Prothrombin Time measures how long it takes for a clot to form in a blood sample. Change from baseline in hematology parameter: prothrombin time at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Hematology Parameter: Prothrombin Time Day 2	-0.12 seconds Standard Deviation 0.183	0.04 seconds Standard Deviation 0.245	0.14 seconds Standard Deviation 0.396
Change From Baseline in Hematology Parameter: Prothrombin Time Follow- up (Day 6)	0.12 seconds Standard Deviation 0.337	-0.06 seconds Standard Deviation 0.510	-0.19 seconds Standard Deviation 0.336

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Amylase, Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Lipase. Change from baseline in chemistry parameters: ALT, ALP, Amylase, AST, CK, GGT, LDH and Lipase at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase ALT: Day 2	0.9 units per litre (U/L) Standard Deviation 2.23	-9.4 units per litre (U/L) Standard Deviation 17.00	-2.0 units per litre (U/L) Standard Deviation 3.82
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase ALT: follow- up (Day 6)	0.8 units per litre (U/L) Standard Deviation 2.12	-7.0 units per litre (U/L) Standard Deviation 20.50	-0.4 units per litre (U/L) Standard Deviation 2.13
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase ALP: follow- up (Day 6)	0.4 units per litre (U/L) Standard Deviation 5.66	-9.5 units per litre (U/L) Standard Deviation 14.06	-9.5 units per litre (U/L) Standard Deviation 19.27
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase Amylase: Day 2	1.8 units per litre (U/L) Standard Deviation 15.71	-11.0 units per litre (U/L) Standard Deviation 8.32	34.1 units per litre (U/L) Standard Deviation 107.34
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase Amylase: follow- up (Day 6)	-4.1 units per litre (U/L) Standard Deviation 6.47	-2.6 units per litre (U/L) Standard Deviation 3.46	14.1 units per litre (U/L) Standard Deviation 21.56
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase AST: Day 2	-0.5 units per litre (U/L) Standard Deviation 2.88	-24.1 units per litre (U/L) Standard Deviation 51.88	2.1 units per litre (U/L) Standard Deviation 7.38
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase AST: follow- up (Day 6)	0.6 units per litre (U/L) Standard Deviation 1.92	-15.5 units per litre (U/L) Standard Deviation 51.39	0.8 units per litre (U/L) Standard Deviation 5.01
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase CK: Day 2	-41.9 units per litre (U/L) Standard Deviation 40.65	-68.0 units per litre (U/L) Standard Deviation 27.44	-36.4 units per litre (U/L) Standard Deviation 23.08
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase CK: follow- up (Day 6)	-20.9 units per litre (U/L) Standard Deviation 44.97	-15.4 units per litre (U/L) Standard Deviation 26.42	-9.5 units per litre (U/L) Standard Deviation 43.36
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase GGT: Day 2	-0.8 units per litre (U/L) Standard Deviation 1.39	-22.4 units per litre (U/L) Standard Deviation 34.98	6.5 units per litre (U/L) Standard Deviation 52.11
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase GGT: follow- up (Day 6)	-1.0 units per litre (U/L) Standard Deviation 1.85	-24.8 units per litre (U/L) Standard Deviation 43.48	-27.6 units per litre (U/L) Standard Deviation 43.00
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase LDH: Day 2	-17.6 units per litre (U/L) Standard Deviation 17.44	-42.5 units per litre (U/L) Standard Deviation 35.62	-11.3 units per litre (U/L) Standard Deviation 33.72
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase LDH: follow- up (Day 6)	-13.9 units per litre (U/L) Standard Deviation 10.44	-20.9 units per litre (U/L) Standard Deviation 23.73	-10.8 units per litre (U/L) Standard Deviation 12.71
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase Lipase: Day 2	18.4 units per litre (U/L) Standard Deviation 50.86	-4.8 units per litre (U/L) Standard Deviation 3.62	-16.8 units per litre (U/L) Standard Deviation 63.92
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase Lipase: follow- up (Day 6)	-2.4 units per litre (U/L) Standard Deviation 7.05	-1.5 units per litre (U/L) Standard Deviation 5.35	10.4 units per litre (U/L) Standard Deviation 28.61
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase, Lipase ALP: Day 2	-3.3 units per litre (U/L) Standard Deviation 5.47	-14.6 units per litre (U/L) Standard Deviation 16.04	-16.1 units per litre (U/L) Standard Deviation 13.17

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the chemistry parameters: Albumin and Protein. Change from baseline in chemistry parameters: albumin and protein level at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Chemistry Parameters: Albumin and Protein Albumin: Day 2	-1.1 g/L Standard Deviation 2.64	-4.0 g/L Standard Deviation 3.74	-2.3 g/L Standard Deviation 3.11
Change From Baseline in Chemistry Parameters: Albumin and Protein Albumin: follow- up (Day 6)	-0.6 g/L Standard Deviation 2.00	-1.5 g/L Standard Deviation 2.73	-0.8 g/L Standard Deviation 0.89
Change From Baseline in Chemistry Parameters: Albumin and Protein Protein: Day 2	-1.3 g/L Standard Deviation 3.11	-6.0 g/L Standard Deviation 5.98	-3.3 g/L Standard Deviation 4.86
Change From Baseline in Chemistry Parameters: Albumin and Protein Protein: follow- up (Day 6)	-1.0 g/L Standard Deviation 2.88	-2.8 g/L Standard Deviation 4.92	-1.5 g/L Standard Deviation 1.93

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the chemistry parameters: Bilirubin, Creatinine and Urate. Change from baseline in chemistry parameters: bilirubin, creatinine and urate level at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Bilirubin: Day 2	-0.42760 micromole per liter (mcmol/L) Standard Deviation 1.516108	3.41455 micromole per liter (mcmol/L) Standard Deviation 7.539097	3.20700 micromole per liter (mcmol/L) Standard Deviation 7.993130
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Bilirubin: follow- up (Day 6)	0.21380 micromole per liter (mcmol/L) Standard Deviation 2.131883	-0.21380 micromole per liter (mcmol/L) Standard Deviation 5.593931	-2.77940 micromole per liter (mcmol/L) Standard Deviation 6.060122
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Creatinine: Day 2	-7.0720 micromole per liter (mcmol/L) Standard Deviation 5.21913	-3.0940 micromole per liter (mcmol/L) Standard Deviation 5.88280	-5.3040 micromole per liter (mcmol/L) Standard Deviation 5.78714
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Creatinine: follow- up (Day 6)	-0.0000 micromole per liter (mcmol/L) Standard Deviation 4.84187	1.7680 micromole per liter (mcmol/L) Standard Deviation 4.77220	-0.4420 micromole per liter (mcmol/L) Standard Deviation 2.87421
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Urate: Day 2	-25.2790 micromole per liter (mcmol/L) Standard Deviation 28.03413	-24.5355 micromole per liter (mcmol/L) Standard Deviation 35.89100	-15.6135 micromole per liter (mcmol/L) Standard Deviation 28.06792
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Urate Urate: follow- up (Day 6)	5.9480 micromole per liter (mcmol/L) Standard Deviation 38.80879	-11.8960 micromole per liter (mcmol/L) Standard Deviation 25.82908	8.9220 micromole per liter (mcmol/L) Standard Deviation 18.80923

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the chemistry parameter: C Reactive Protein. Change from baseline in chemistry parameters: C Reactive Protein level at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Chemistry Parameter: C Reactive Protein Day 2	-0.04 milligram per liter (mg/L) Standard Deviation 0.460	-0.22 milligram per liter (mg/L) Standard Deviation 0.669	0.40 milligram per liter (mg/L) Standard Deviation 1.593
Change From Baseline in Chemistry Parameter: C Reactive Protein Follow- up (Day 6)	-0.05 milligram per liter (mg/L) Standard Deviation 0.404	0.26 milligram per liter (mg/L) Standard Deviation 0.798	1.25 milligram per liter (mg/L) Standard Deviation 2.330

SECONDARY outcome

Timeframe: Baseline, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Blood samples were collected in a fasted condition (after a fast of at least 8 hours) to analyze the chemistry parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen. Change from baseline in chemistry parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen level at Day 2 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Potassium: follow- up (Day 6)	-0.01 millimole per liter (mmol/L) Standard Deviation 0.181	0.16 millimole per liter (mmol/L) Standard Deviation 0.396	-0.38 millimole per liter (mmol/L) Standard Deviation 0.727
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Calcium: Day 2	-0.030 millimole per liter (mmol/L) Standard Deviation 0.0481	-0.020 millimole per liter (mmol/L) Standard Deviation 0.0878	-0.036 millimole per liter (mmol/L) Standard Deviation 0.0540
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Calcium: follow- up (Day 6)	-0.039 millimole per liter (mmol/L) Standard Deviation 0.0506	-0.033 millimole per liter (mmol/L) Standard Deviation 0.1074	-0.090 millimole per liter (mmol/L) Standard Deviation 0.1158
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Chloride: Day 2	1.0 millimole per liter (mmol/L) Standard Deviation 1.07	0.5 millimole per liter (mmol/L) Standard Deviation 2.27	2.4 millimole per liter (mmol/L) Standard Deviation 0.92
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Chloride: follow- up (Day 6)	-1.6 millimole per liter (mmol/L) Standard Deviation 2.07	-0.4 millimole per liter (mmol/L) Standard Deviation 1.60	1.6 millimole per liter (mmol/L) Standard Deviation 2.62
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Cholesterol: Day 2	0.03885 millimole per liter (mmol/L) Standard Deviation 0.287412	-0.26871 millimole per liter (mmol/L) Standard Deviation 0.539200	-0.18778 millimole per liter (mmol/L) Standard Deviation 0.233203
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Cholesterol: follow- up (Day 6)	-0.27519 millimole per liter (mmol/L) Standard Deviation 0.477560	-0.38203 millimole per liter (mmol/L) Standard Deviation 0.701523	-0.21691 millimole per liter (mmol/L) Standard Deviation 0.274776
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Glucose: Day 2	0.09019 millimole per liter (mmol/L) Standard Deviation 0.622942	0.05550 millimole per liter (mmol/L) Standard Deviation 1.760321	-1.94944 millimole per liter (mmol/L) Standard Deviation 2.490078
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Glucose: follow- up (Day 6)	0.17344 millimole per liter (mmol/L) Standard Deviation 0.379258	-0.32606 millimole per liter (mmol/L) Standard Deviation 0.340109	-1.87313 millimole per liter (mmol/L) Standard Deviation 3.549490
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Magnesium: Day 2	-0.009 millimole per liter (mmol/L) Standard Deviation 0.0285	-0.052 millimole per liter (mmol/L) Standard Deviation 0.0742	-0.001 millimole per liter (mmol/L) Standard Deviation 0.0732
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Magnesium: follow- up (Day 6)	-0.014 millimole per liter (mmol/L) Standard Deviation 0.0297	0.005 millimole per liter (mmol/L) Standard Deviation 0.0457	-0.006 millimole per liter (mmol/L) Standard Deviation 0.0758
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Phosphate: Day 2	0.003 millimole per liter (mmol/L) Standard Deviation 0.0509	0.080 millimole per liter (mmol/L) Standard Deviation 0.0953	0.105 millimole per liter (mmol/L) Standard Deviation 0.1872
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Phosphate: follow- up (Day 6)	-0.005 millimole per liter (mmol/L) Standard Deviation 0.0682	-0.064 millimole per liter (mmol/L) Standard Deviation 0.1421	-0.106 millimole per liter (mmol/L) Standard Deviation 0.1897
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Potassium: Day 2	-0.11 millimole per liter (mmol/L) Standard Deviation 0.356	-0.12 millimole per liter (mmol/L) Standard Deviation 0.266	-0.34 millimole per liter (mmol/L) Standard Deviation 0.487
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Sodium: Day 2	0.0 millimole per liter (mmol/L) Standard Deviation 1.60	-2.8 millimole per liter (mmol/L) Standard Deviation 1.39	-0.1 millimole per liter (mmol/L) Standard Deviation 2.36
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Sodium: follow- up (Day 6)	-0.6 millimole per liter (mmol/L) Standard Deviation 1.77	-0.9 millimole per liter (mmol/L) Standard Deviation 1.25	1.8 millimole per liter (mmol/L) Standard Deviation 2.76
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Triglycerides: Day 2	-0.15538 millimole per liter (mmol/L) Standard Deviation 0.940507	0.06356 millimole per liter (mmol/L) Standard Deviation 0.222415	-0.44776 millimole per liter (mmol/L) Standard Deviation 1.268752
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Triglycerides: follow- up (Day 6)	-0.23165 millimole per liter (mmol/L) Standard Deviation 0.875919	-0.02260 millimole per liter (mmol/L) Standard Deviation 0.326110	-0.40539 millimole per liter (mmol/L) Standard Deviation 0.781335
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Urea: Day 2	-0.021 millimole per liter (mmol/L) Standard Deviation 0.9152	0.531 millimole per liter (mmol/L) Standard Deviation 0.7122	0.765 millimole per liter (mmol/L) Standard Deviation 0.8025
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Urea: follow- up (Day 6)	-0.213 millimole per liter (mmol/L) Standard Deviation 1.0149	0.149 millimole per liter (mmol/L) Standard Deviation 0.5849	0.340 millimole per liter (mmol/L) Standard Deviation 0.2570
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Urea Nitrogen: Day 2	0.0000 millimole per liter (mmol/L) Standard Deviation 0.89505	0.5801 millimole per liter (mmol/L) Standard Deviation 0.71240	0.7586 millimole per liter (mmol/L) Standard Deviation 0.77366
Change From Baseline in Chemistry Parameters: Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea and Urea Nitrogen Urea Nitrogen: follow- up (Day 6)	-0.2231 millimole per liter (mmol/L) Standard Deviation 0.99041	0.1785 millimole per liter (mmol/L) Standard Deviation 0.57247	0.3570 millimole per liter (mmol/L) Standard Deviation 0.26987

SECONDARY outcome

Timeframe: Baseline, Day 1 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position by using an ECG machine that automatically calculates the heart rate. Change from baseline in 12-lead ECG parameter: heart rate at Day 1 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameter: Heart Rate Day 1	0.3 beats per minute Standard Deviation 5.18	-0.9 beats per minute Standard Deviation 5.33	0.9 beats per minute Standard Deviation 2.70
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameter: Heart Rate Follow- up (Day 6)	11.8 beats per minute Standard Deviation 11.02	7.4 beats per minute Standard Deviation 11.34	5.8 beats per minute Standard Deviation 6.34

SECONDARY outcome

Timeframe: Baseline, Day 1 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position by using an ECG machine that automatically measures PQ/PR, QRS, QT, and QTc intervals and RR duration. Change From Baseline in 12-ECG parameters: PQ/PR interval, QRS duration, QT interval, QTcF interval and RR duration at Day 1 and Day 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 PQ/PR Duration: Day 1	-0.3 milliseconds Standard Deviation 4.71	0.3 milliseconds Standard Deviation 4.46	-2.0 milliseconds Standard Deviation 17.47
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 PQ/PR Duration: follow-up (Day 6)	-12.5 milliseconds Standard Deviation 11.05	-4.5 milliseconds Standard Deviation 9.78	-10.0 milliseconds Standard Deviation 13.52
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QRS Duration :Day 1	0.0 milliseconds Standard Deviation 3.21	2.3 milliseconds Standard Deviation 5.06	6.5 milliseconds Standard Deviation 9.06
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QRS Duration: follow-up (Day 6)	-1.3 milliseconds Standard Deviation 3.01	3.0 milliseconds Standard Deviation 8.28	-2.0 milliseconds Standard Deviation 7.63
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QT Duration: Day 1	-7.3 milliseconds Standard Deviation 17.33	-0.3 milliseconds Standard Deviation 11.97	-0.5 milliseconds Standard Deviation 12.99
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QT Duration: follow-up (Day 6)	-24.3 milliseconds Standard Deviation 18.77	-5.5 milliseconds Standard Deviation 22.72	-7.0 milliseconds Standard Deviation 20.45
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QTcF - Fridericia's Correction Formula: Day 1	-6.8 milliseconds Standard Deviation 20.11	-1.8 milliseconds Standard Deviation 4.89	1.5 milliseconds Standard Deviation 11.76
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 QTcF - Fridericia's Correction Formula: follow-up (Day 6)	-2.4 milliseconds Standard Deviation 9.98	9.1 milliseconds Standard Deviation 11.49	2.9 milliseconds Standard Deviation 15.61
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 RR Duration: Day 1	-6.1 milliseconds Standard Deviation 79.08	9.0 milliseconds Standard Deviation 92.82	-11.0 milliseconds Standard Deviation 37.85
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: PQ/PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) and RR Duration at Day 1 and Day 6 RR Duration: follow-up (Day 6)	-148.1 milliseconds Standard Deviation 126.54	-87.4 milliseconds Standard Deviation 130.73	-67.4 milliseconds Standard Deviation 91.17

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in SBP and DBP at Days 1, 2 and 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: Day 1	3.5 millimeters of mercury (mmHg) Standard Deviation 12.95	-3.6 millimeters of mercury (mmHg) Standard Deviation 3.58	2.0 millimeters of mercury (mmHg) Standard Deviation 6.70
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: Day 2	5.6 millimeters of mercury (mmHg) Standard Deviation 6.97	4.8 millimeters of mercury (mmHg) Standard Deviation 13.05	-1.1 millimeters of mercury (mmHg) Standard Deviation 8.68
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: follow-up (Day 6)	0.1 millimeters of mercury (mmHg) Standard Deviation 15.58	4.8 millimeters of mercury (mmHg) Standard Deviation 5.99	0.9 millimeters of mercury (mmHg) Standard Deviation 13.21
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: Day 1	1.4 millimeters of mercury (mmHg) Standard Deviation 6.86	-3.5 millimeters of mercury (mmHg) Standard Deviation 7.17	-2.0 millimeters of mercury (mmHg) Standard Deviation 4.34
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: Day 2	1.9 millimeters of mercury (mmHg) Standard Deviation 4.58	0.6 millimeters of mercury (mmHg) Standard Deviation 5.07	-1.9 millimeters of mercury (mmHg) Standard Deviation 4.52
Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: follow-up (Day 6)	1.0 millimeters of mercury (mmHg) Standard Deviation 7.37	3.3 millimeters of mercury (mmHg) Standard Deviation 4.74	0.5 millimeters of mercury (mmHg) Standard Deviation 7.73

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Change from baseline in vital sign parameter: pulse rate at Days 1, 2 and 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Vital Sign Parameter: Pulse Rate Day 1	1.1 beats per minute Standard Deviation 2.42	1.5 beats per minute Standard Deviation 8.26	-1.4 beats per minute Standard Deviation 5.53
Change From Baseline in Vital Sign Parameter: Pulse Rate Day 2	11.3 beats per minute Standard Deviation 5.18	7.4 beats per minute Standard Deviation 7.78	8.8 beats per minute Standard Deviation 5.34
Change From Baseline in Vital Sign Parameter: Pulse Rate Follow-up (Day 6)	11.0 beats per minute Standard Deviation 8.07	3.6 beats per minute Standard Deviation 7.31	5.9 beats per minute Standard Deviation 6.17

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Change from baseline in vital sign parameter: respiratory rate at Days 1, 2 and 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Vital Sign Parameter: Respiratory Rate Day 1	-1.0 breaths per minute Standard Deviation 1.69	0.9 breaths per minute Standard Deviation 1.64	-0.6 breaths per minute Standard Deviation 1.30
Change From Baseline in Vital Sign Parameter: Respiratory Rate Day 2	1.5 breaths per minute Standard Deviation 2.33	0.0 breaths per minute Standard Deviation 1.51	-0.8 breaths per minute Standard Deviation 2.43
Change From Baseline in Vital Sign Parameter: Respiratory Rate Follow-up (Day 6)	1.0 breaths per minute Standard Deviation 3.02	-0.5 breaths per minute Standard Deviation 0.93	-0.1 breaths per minute Standard Deviation 1.46

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 2 and follow-up (Day 6)

Population: SAF included all participants who were administered any dose of any study intervention.

Temperature was measured in the semi-supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Change from baseline in vital sign parameter: temperature at Days 1, 2 and 6 were reported.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Change From Baseline in Vital Sign Parameter: Temperature Day 1	-0.04 degree celsius Standard Deviation 0.366	-0.00 degree celsius Standard Deviation 0.438	-0.01 degree celsius Standard Deviation 0.270
Change From Baseline in Vital Sign Parameter: Temperature Day 2	0.46 degree celsius Standard Deviation 0.463	0.05 degree celsius Standard Deviation 0.396	0.19 degree celsius Standard Deviation 0.348
Change From Baseline in Vital Sign Parameter: Temperature Follow-up (Day 6)	0.21 degree celsius Standard Deviation 0.223	0.14 degree celsius Standard Deviation 0.444	0.16 degree celsius Standard Deviation 0.354

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

Tmax was obtained directly from the concentration versus time curve.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Time to Reach the Maximum Plasma Concentration (Tmax) of M2951	2.00 hours Interval 1.0 to 4.0	1.76 hours Interval 0.5 to 3.02	1.75 hours Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. T1/2 was calculated by natural log 2 divided by Lambda z. Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Apparent Elimination Half Life (t1/2) of M2951	1.54 hours Interval 1.02 to 1.67	2.55 hours Interval 1.55 to 6.56	2.65 hours Interval 1.81 to 3.02

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0 and 12.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

AUC0-12 of M2951 was defined as the area under the plasma concentration time curve from time 0 to 12 hours post-dose.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Area Under The Plasma Concentration-Time Curve From Time Zero to Time 12 Hours (AUC0-12) of M2951	184 h*ng/mL Geometric Coefficient of Variation 23.6	224 h*ng/mL Geometric Coefficient of Variation 59.7	351 h*ng/mL Geometric Coefficient of Variation 21.7

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0 and 24.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

AUC0-24 of M2951 was defined as the area under the plasma concentration time curve from time 0 to 24 hours post-dose.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours (AUC0-24) of M2951	185 h*ng/mL Geometric Coefficient of Variation 23.8	231 h*ng/mL Geometric Coefficient of Variation 60.1	360 h*ng/mL Geometric Coefficient of Variation 22.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-tlast was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of M2951	184 h*ng/mL Geometric Coefficient of Variation 23.9	228 h*ng/mL Geometric Coefficient of Variation 60.9	357 h*ng/mL Geometric Coefficient of Variation 22.3

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

CL/f was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. CL/f was calculated as Dose/AUC0-inf, where AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. AUC0-inf was calculated as AUC0-t + Clast pred/Lambda Z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the lower limit of quantification (LLOQ) and Lambda Z was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Apparent Total Body Clearance (CL/f) of M2951	162 liter per hour (L/h) Geometric Coefficient of Variation 23.6	129 liter per hour (L/h) Geometric Coefficient of Variation 60.6	82.9 liter per hour (L/h) Geometric Coefficient of Variation 21.8

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 32.0 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing. Vz/f = Dose/(AUC0-infinity multiply by Lambda z) following single dose. AUC0-inf was calculated by combining AUC0-tlast and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Apparent Volume of Distribution During Terminal Phase (VZ/f) of M2951	337 liters Geometric Coefficient of Variation 15.2	498 liters Geometric Coefficient of Variation 53.4	301 liters Geometric Coefficient of Variation 27.0

SECONDARY outcome

Timeframe: 1.5, 4, and 12 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

fu is defined as the ratio of unbound drug concentration to the total drug concentration.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Fraction of Unbound Drug (fu) of M2951	5.00 ratio of unbound drug Geometric Coefficient of Variation 15.3	5.78 ratio of unbound drug Geometric Coefficient of Variation 17.9	6.55 ratio of unbound drug Geometric Coefficient of Variation 11.9

SECONDARY outcome

Timeframe: 1.5, 4, and 12 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

AUC0-inf,u was calculated as fu * AUC0-inf. fu was defined as the ratio of unbound drug concentration to the total drug concentration. AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Area Under Plasma Concentration for Unbound Drug (M2951) From Time Zero to Infinity (AUC0-inf,u)	9.28 h*ng/mL Geometric Coefficient of Variation 30.3	13.4 h*ng/mL Geometric Coefficient of Variation 71.7	23.7 h*ng/mL Geometric Coefficient of Variation 28.5

SECONDARY outcome

Timeframe: 1.5, 4, and 12 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

Cmax,u was calculated as fu * Cmax. fu was defined as the ratio of unbound drug concentration to the total drug concentration. Cmax was obtained directly from the concentration versus time curve.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Maximum Observed Plasma Concentration of Unbound M2951 (Cmax, u)	3.19 ng/mL Geometric Coefficient of Variation 22.8	4.57 ng/mL Geometric Coefficient of Variation 92.6	7.72 ng/mL Geometric Coefficient of Variation 36.1

SECONDARY outcome

Timeframe: 1.5, 4, and 12 hours post-dose

Population: The PK Population was a subset of the SAF analysis population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. A measurement BLQ was considered a valid measurement.

CL,u/F was calculated as Dose divided by AUC0-inf, u. AUC0-inf,u was calculated as fu * AUC0-inf. fu was defined as the ratio of unbound drug concentration to the total drug concentration. AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Measure	Group 1: Normal Hepatic Function (Reference) n=8 Participants Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 Participants Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 Participants Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Apparent Oral Clearance (CL,u/F) of Unbound M2951	3230 L/h Geometric Coefficient of Variation 30.3	2240 L/h Geometric Coefficient of Variation 71.7	1270 L/h Geometric Coefficient of Variation 28.5

Adverse Events

Group 1: Normal Hepatic Function (Reference)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2: Mild Hepatic Impairment (Child-Pugh Class A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3: Moderate Hepatic Impairment (Child-Pugh Class B)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1: Normal Hepatic Function (Reference) n=8 participants at risk Participants with normal hepatic function received single oral dose of 30 milligrams (mg) M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast.	Group 2: Mild Hepatic Impairment (Child-Pugh Class A) n=8 participants at risk Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.	Group 3: Moderate Hepatic Impairment (Child-Pugh Class B) n=8 participants at risk Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 30 mg M2951 (3 film-coated tablets of 10 mg) on Day 1 after a standard breakfast. The Child-Pugh Score was a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon serum albumin, ascites, serum bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • up to follow-up (Day 6)	0.00% 0/8 • up to follow-up (Day 6)	12.5% 1/8 • up to follow-up (Day 6)

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Submission of publications to Merck for review at least 60 days prior planned publication. Merck has to provide feedback within 60 days, if any confidential information other than study data is concerned. Should any patent rights be effected, Merck has right to delay publication for another 60 days for patent filing.
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Restriction type: OTHER