Healthy Participants, Hepatic Impairment
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis
Brief summary
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
Interventions
DRUGPF-06835919 25 mg
PF-06835919 in 25 mg oral tablet will be administered on Day 1
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants between the ages of 18 (or the minimum country specific age of consent if \>18) and 70 years, inclusive, at the Screening visit: * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight \>50 kg (110 lb). * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Exclusion criteria
* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection). (Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening).. * At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor identified central laboratory, with a single repeat permitted to assess eligibility, if needed. * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Use of prior/concomitant therapies. * Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer). * Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06835919. * A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test at Screening. However, participants who have been medially prescribed opiates/opiods or benzodiazepines and report the use of these drugs to the investigator at the screening visit will be allowed to participate. * Male participants with partners who are currently pregnant. * Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact. * History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections. * Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol. * Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of Drug Unbound (fu) of PF-06835919 | Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1. | The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant. |
| Maximum Plasma Concentration (Cmax) of PF-06835919 | Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1. | Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data. |
| Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919 | Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1. | AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time. |
| Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919 | Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1. | Cmax,u was defined as unbound maximum plasma concentration. |
| Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 | Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1. | AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Baseline (Day 1) up to Day 6 | To determine if there were any clinically significant laboratory abnormalities, hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, lymphocytes, neutrophils, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio), clinical chemistry (bilirubin, direct and indirect bilirubin, gamma glutamyl transferase, albumin, urea nitrogen, glucose) and urinalysis (glucose, protein, hemoglobin, urobilinogen, nitrite) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria. |
| Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | Baseline (Day 1) up to Day 6 | ECG endpoints (PR interval, QRS interval, QT interval and QTcF) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. PR max. ≥300ms, %Chg ≥25/50%; 3. QRS max. ≥140ms，%Chg ≥50%; 3.maximum post-dose QTcF 450 - ≤480msec, 480 - ≤500msec and \>500msec, 30\<Chg≤60 and Chg\>60. |
| Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | Baseline (Day 1) up to follow-up (Day 31) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AE (TEAE) was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs. |
Countries
Belgium, Czechia, Slovakia
Participant flow
Pre-assignment details
A total of 34 participants were screened, of whom 11 had screen failure and 23 entered the study. There were 6, 6, 6 and 5 participants in the without hepatic impairment group, mild hepatic impairment group, moderate hepatic impairment group and severe hepatic impairment group, respectively. All of the 23 treated participants received their assigned treatment, and no participant discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Without Hepatic Impairment This arm included participants without hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1. | 6 |
| Mild Hepatic Impairment This arm included participants with mild hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1. | 6 |
| Moderate Hepatic Impairment This arm included participants with moderate hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1. | 6 |
| Severe Hepatic Impairment This arm included participants with severe hepatic impairment who received a 25 mg single oral dose of PF-06835919 on Day 1. | 5 |
| Total | 23 |
Baseline characteristics
| Characteristic | Without Hepatic Impairment | Mild Hepatic Impairment | Moderate Hepatic Impairment | Severe Hepatic Impairment | Total |
|---|---|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized ≥65 years | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 12 Participants |
| Age, Customized Between 18 and 64 years (inclusive) | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 23 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 5 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 1 / 6 | 1 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919
AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Hepatic Impairment | Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 | 14090 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 29 |
| Mild Hepatic Impairment | Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 | 13090 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 36 |
| Moderate Hepatic Impairment | Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 | 18930 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34 |
| Severe Hepatic Impairment | Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 | 19630 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28 |
Comparison: The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.90% CI: [68.15, 126.6]
Comparison: The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [98.61, 183.17]
Comparison: The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [100.69, 192.78]
Primary
Fraction of Drug Unbound (fu) of PF-06835919
The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Hepatic Impairment | Fraction of Drug Unbound (fu) of PF-06835919 | 0.04345 ratio | Geometric Coefficient of Variation 5 |
| Mild Hepatic Impairment | Fraction of Drug Unbound (fu) of PF-06835919 | 0.05704 ratio | Geometric Coefficient of Variation 21 |
| Moderate Hepatic Impairment | Fraction of Drug Unbound (fu) of PF-06835919 | 0.05780 ratio | Geometric Coefficient of Variation 18 |
| Severe Hepatic Impairment | Fraction of Drug Unbound (fu) of PF-06835919 | 0.06111 ratio | Geometric Coefficient of Variation 14 |
Primary
Maximum Plasma Concentration (Cmax) of PF-06835919
Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Hepatic Impairment | Maximum Plasma Concentration (Cmax) of PF-06835919 | 1310 ng/mL | Geometric Coefficient of Variation 17 |
| Mild Hepatic Impairment | Maximum Plasma Concentration (Cmax) of PF-06835919 | 1143 ng/mL | Geometric Coefficient of Variation 47 |
| Moderate Hepatic Impairment | Maximum Plasma Concentration (Cmax) of PF-06835919 | 1340 ng/mL | Geometric Coefficient of Variation 28 |
| Severe Hepatic Impairment | Maximum Plasma Concentration (Cmax) of PF-06835919 | 1098 ng/mL | Geometric Coefficient of Variation 31 |
Comparison: The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [63.61, 119.53]
Comparison: The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [74.59, 140.15]
Comparison: The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [60.18, 116.62]
Primary
Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919
AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Hepatic Impairment | Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919 | 612.6 ng*hr/mL | Geometric Coefficient of Variation 29 |
| Mild Hepatic Impairment | Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919 | 746.2 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Moderate Hepatic Impairment | Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919 | 1093 ng*hr/mL | Geometric Coefficient of Variation 43 |
| Severe Hepatic Impairment | Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919 | 1199 ng*hr/mL | Geometric Coefficient of Variation 34 |
Comparison: The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [88.69, 167.31]
Comparison: The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [129.96, 245.18]
Comparison: The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [140.31, 273.03]
Primary
Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919
Cmax,u was defined as unbound maximum plasma concentration.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Population: The PK parameter analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Hepatic Impairment | Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919 | 56.93 ng/mL | Geometric Coefficient of Variation 18 |
| Mild Hepatic Impairment | Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919 | 65.16 ng/mL | Geometric Coefficient of Variation 32 |
| Moderate Hepatic Impairment | Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919 | 77.45 ng/mL | Geometric Coefficient of Variation 26 |
| Severe Hepatic Impairment | Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919 | 67.10 ng/mL | Geometric Coefficient of Variation 30 |
Comparison: The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [88.13, 148.63]
Comparison: The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [104.75, 176.67]
Comparison: The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.90% CI: [89.61, 155.03]
Secondary
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AE (TEAE) was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.
Time frame: Baseline (Day 1) up to follow-up (Day 31)
Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Without Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With all-causality TEAE | 0 Participants |
| Without Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With SAE | 0 Participants |
| Without Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With treatment-related TEAE | 0 Participants |
| Mild Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With all-causality TEAE | 0 Participants |
| Mild Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With SAE | 0 Participants |
| Mild Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With treatment-related TEAE | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With treatment-related TEAE | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With all-causality TEAE | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With SAE | 0 Participants |
| Severe Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With all-causality TEAE | 1 Participants |
| Severe Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With SAE | 0 Participants |
| Severe Hepatic Impairment | Number of Participants Reporting Treatment-emergent Adverse Events (AEs) | With treatment-related TEAE | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
To determine if there were any clinically significant laboratory abnormalities, hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, lymphocytes, neutrophils, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio), clinical chemistry (bilirubin, direct and indirect bilirubin, gamma glutamyl transferase, albumin, urea nitrogen, glucose) and urinalysis (glucose, protein, hemoglobin, urobilinogen, nitrite) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.
Time frame: Baseline (Day 1) up to Day 6
Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Lymphocytes (10^3/mm3) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Hemoglobin ≥1 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Neutrophils (10^3/mm3) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Protein (mg/dL) ≥1 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Erythrocytes (10^6/mm3) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Nitrite ≥1 | 1 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Glucose (mg/dL) ≥1 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Volume (um^3) >1.1*upper limit of normal (ULN) | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urobilinogen (EU/dL) ≥1 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hematocrit (%) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Platelets (10^3/mm3) <0.8*LLN | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hemoglobin (g/dL) <0.8*lower limit of normal (LLN) | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Glucose (mg/dL) >1.5*ULN | 1 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hemoglobin (g/dL) <0.8*lower limit of normal (LLN) | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hematocrit (%) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Erythrocytes (10^6/mm3) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Volume (um^3) >1.1*upper limit of normal (ULN) | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Platelets (10^3/mm3) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Lymphocytes (10^3/mm3) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Neutrophils (10^3/mm3) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urea Nitrogen (mg/dL) >1.3*ULN | 1 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Glucose (mg/dL) ≥1 | 1 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Protein (mg/dL) ≥1 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Hemoglobin ≥1 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urobilinogen (EU/dL) ≥1 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Nitrite ≥1 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Glucose (mg/dL) >1.5*ULN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Bilirubin (mg/dL) >1.5*ULN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Erythrocytes (10^6/mm3) <0.8*LLN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 2 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Glucose (mg/dL) ≥1 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Platelets (10^3/mm3) <0.8*LLN | 3 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Nitrite ≥1 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hemoglobin (g/dL) <0.8*lower limit of normal (LLN) | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Neutrophils (10^3/mm3) <0.8*LLN | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Protein (mg/dL) ≥1 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Hemoglobin ≥1 | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urobilinogen (EU/dL) ≥1 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Time (sec) >1.1*ULN | 5 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Lymphocytes (10^3/mm3) <0.8*LLN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hematocrit (%) <0.8*LLN | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Intl. Normalized Ratio >1.1*ULN | 5 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Direct Bilirubin (mg/dL) >1.5*ULN | 4 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Volume (um^3) >1.1*upper limit of normal (ULN) | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Platelets (10^3/mm3) <0.8*LLN | 4 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Bilirubin (mg/dL) >1.5*ULN | 5 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Direct Bilirubin (mg/dL) >1.5*ULN | 5 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Hemoglobin ≥1 | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Indirect Bilirubin (mg/dL) >1.5*ULN | 2 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hemoglobin (g/dL) <0.8*lower limit of normal (LLN) | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Gamma Glutamyl Transferase (U/L) >3.0*ULN | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Albumin (g/dL) <0.8*LLN | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Ery. Mean Corpuscular Volume (um^3) >1.1*upper limit of normal (ULN) | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Erythrocytes (10^6/mm3) <0.8*LLN | 2 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Urobilinogen (EU/dL) ≥1 | 5 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Glucose (mg/dL) ≥1 | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Hematocrit (%) <0.8*LLN | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Neutrophils (10^3/mm3) <0.8*LLN | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 2 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Lymphocytes (10^3/mm3) <0.8*LLN | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | URINE Protein (mg/dL) ≥1 | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Time (sec) >1.1*ULN | 5 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Prothrombin Intl. Normalized Ratio >1.1*ULN | 5 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests | Nitrite ≥1 | 1 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
ECG endpoints (PR interval, QRS interval, QT interval and QTcF) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. PR max. ≥300ms, %Chg ≥25/50%; 3. QRS max. ≥140ms，%Chg ≥50%; 3.maximum post-dose QTcF 450 - ≤480msec, 480 - ≤500msec and \>500msec, 30\<Chg≤60 and Chg\>60.
Time frame: Baseline (Day 1) up to Day 6
Population: The safety analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval Value ≥300 msec | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval %Chg ≥25/50% | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval Value ≥140 msec | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval %Chg ≥50% | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QT Interval Value >500 msec | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 450< Value ≤480 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 480< Value ≤500 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Value >500 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 30< Chg ≤60 | 0 Participants |
| Without Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Chg >60 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval Value ≥140 msec | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 30< Chg ≤60 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval %Chg ≥50% | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QT Interval Value >500 msec | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 450< Value ≤480 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 480< Value ≤500 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Chg >60 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Value >500 | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval Value ≥300 msec | 0 Participants |
| Mild Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval %Chg ≥25/50% | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Value >500 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 480< Value ≤500 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Chg >60 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval Value ≥300 msec | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval %Chg ≥50% | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 450< Value ≤480 | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 30< Chg ≤60 | 1 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval %Chg ≥25/50% | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QT Interval Value >500 msec | 0 Participants |
| Moderate Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval Value ≥140 msec | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QT Interval Value >500 msec | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Value >500 | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 450< Value ≤480 | 2 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) Chg >60 | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 480< Value ≤500 | 1 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval %Chg ≥25/50% | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval Value ≥140 msec | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QRS Interval %Chg ≥50% | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | PR Interval Value ≥300 msec | 0 Participants |
| Severe Hepatic Impairment | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs) | QTcF (msec) 30< Chg ≤60 | 0 Participants |