Healthy Volunteers, Hepatic Impairment
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function.
Detailed description
29-Apr-2020 Enrollment of new participants into this study was paused due to the COVID-19 situation. The duration of this pause was dependent on the leveling and control of the COVID-19 pandemic. The drug being tested in this study is called mobocertinib. The study will assess the PK of single dose mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function. The study will enroll approximately 24 participants. Participants will be assigned to 1 of the following 3 treatment groups in a staggered manner based on their degree of hepatic impairment which will be determined based on Child-Pugh Score as follow: * Moderate HI (Child-Pugh B): Mobocertinib 40 mg * Severe HI (Child-Pugh C): Mobocertinib 40 mg * Normal Hepatic Function: Mobocertinib 40 mg Healthy participants with normal hepatic function will be recruited to match both moderate and severe HI by age (mean plus or minus \[+-\] 10 years), gender (+-2 participants per gender), and body mass index (BMI, mean +-10 percent \[%\]). All participants will be asked to take single dose of mobocertinib on Day 1. The dose level for severe HI may be modified based on the previous results of approximately 3 moderate HI and healthy participants who completed up to Day 10 study procedures. This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 51 days. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
Interventions
DRUGMobocertinib
Mobocertinib capsule.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Healthy Participants 1. Continuous non-smoker or moderate smoker (less than or equal to (\<=) 10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to mobocertinib dosing and throughout the period of PK sample collection. 2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and \<=39.0 kilogram per square meter (kg/m\^2), at screening. Participants will be matched to hepatic impaired participants by BMI (mean plus minus \[+-\] 10%) at screening. At least 50% of the participants will be required to be of BMI \>=18.0 and \<=35.0 kg/m\^2, at screening. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee. Has liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin within the upper limit of normal at screening and at check-in. 4. Creatinine clearance (estimated glomerular filtration rate \[eGFR\]) \>=60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) at screening. Inclusion Criteria for Moderate or Severe HI Participants 1. Continuous non-smoker or moderate smoker (\<=10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to mobocertinib dosing and throughout the period of pharmacokinetic(s) (PK) sample collection. 2. BMI \>=18.0 and \<=39.0 kg/m\^2, at screening. At least 50% of the participants will be required to be of BMI \>=18.0 and \<=35.0 kg/m\^2, at screening. 3. Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed by the Investigator or designee. 4. Creatinine clearance (eGFR) \>=60 mL/min/1.73 m\^2 at screening. 5. Chronic HI for at least 3 months before screening, and the HI must be stable, that is, no significant changes in hepatic function in the 30 days preceding screening (or since the last visit if within 6 months before screening) and treatment with stable doses of medication. Has a score on the Child-Pugh Class at screening as follows: * Moderate HI arm, Child-Pugh Class B: \>=7 and \<=9. * Severe HI arm, Child-Pugh Class C: \>=10 and \<=15.
Exclusion criteria
1. Positive results for COVID-19 at screening or check in. 2. Seated blood pressure is less than 90/40 millimeters of Mercury (mmHg) or greater than 150/95 mmHg at screening. 3. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening. 4. Healthy participants: QTcF interval is \>=450 msec in males or \>=470 msec in females; Moderate or Severe HI participants: QTcF interval is greater than (\>) 500 msec OR has ECG findings deemed abnormal with clinical significance by the Investigator or designee at screening. 5. Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements) for the prohibited time period. 6. Been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study. 7. Donation of blood or had significant blood loss within 56 days prior to dosing. 8. Plasma donation within 7 days prior to dosing. 9. Healthy participants: Positive result at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV); Moderate or Severe HI participants: Positive result at screening for HIV, HBsAg positive participants are allowed to enroll if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is below 1000 copies/milliliter (mL) in the plasma. Participants who are positive for hepatitis C virus antibodies (HCVAb) can be enrolled but must not have detectable HCV ribonucleic acid (RNA) in the plasma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
| λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a plasma concentration against time curve. |
| CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib | Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after last dose of study drug (up to Day 32) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. |
| Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Day 1 at multiple time points (up to 24 hours) post-dose | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in the United States from 09 October 2020 to 26 February 2022.
Pre-assignment details
Participants with a diagnosis of moderate or severe hepatic impairment (HI) were enrolled to receive mobocertinib and were compared to a matched-normal hepatic function arm.
Participants by arm
| Arm | Count |
|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. | 8 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. | 8 |
| Normal Hepatic Function: Mobocertinib 40 mg Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Severe HI (Child-Pugh C): Mobocertinib 40 mg | Total | Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Normal Hepatic Function: Mobocertinib 40 mg |
|---|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 8.64 | 58.9 years STANDARD_DEVIATION 6.54 | 61.1 years STANDARD_DEVIATION 3.76 | 59.4 years STANDARD_DEVIATION 6.09 |
| Body Mass Index (BMI) | 28.378 kg/m^2 STANDARD_DEVIATION 4.5553 | 29.371 kg/m^2 STANDARD_DEVIATION 4.3571 | 29.279 kg/m^2 STANDARD_DEVIATION 4.7428 | 30.456 kg/m^2 STANDARD_DEVIATION 4.0801 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 18 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.4 cm STANDARD_DEVIATION 9.71 | 169.2 cm STANDARD_DEVIATION 9.86 | 170.9 cm STANDARD_DEVIATION 11.72 | 167.4 cm STANDARD_DEVIATION 8.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 22 Participants | 7 Participants | 7 Participants |
| Region of Enrollment United States | 8 Participants | 24 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 6 Participants | 5 Participants |
| Weight | 81.46 kg STANDARD_DEVIATION 14.803 | 84.80 kg STANDARD_DEVIATION 18.622 | 87.06 kg STANDARD_DEVIATION 24.847 | 85.88 kg STANDARD_DEVIATION 16.824 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 0 / 8 | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Number analyzed is the number of participants with data available for analysis for the specified category. Data was not collected for AP32914 as no participant displayed a sufficient PK profile with respect to this parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 206 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 32.7 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 91.6 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 22.2 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 291 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 48.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 115 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 1.94 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 199 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 36.2 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 105 nanogram*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 31.5 |
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 192 ng*h/mL | Geometric Coefficient of Variation 34.2 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 7.61 ng*h/mL | Geometric Coefficient of Variation 48.1 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 69.3 ng*h/mL | Geometric Coefficient of Variation 21.3 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 275 ng*h/mL | Geometric Coefficient of Variation 50.3 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 64.5 ng*h/mL | Geometric Coefficient of Variation 52.1 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 9.32 ng*h/mL | Geometric Coefficient of Variation 91.4 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 186 ng*h/mL | Geometric Coefficient of Variation 38.7 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 12.5 ng*h/mL | Geometric Coefficient of Variation 71.3 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 91.9 ng*h/mL | Geometric Coefficient of Variation 35.1 |
Primary
AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 1.02 ng*h/mL | Geometric Coefficient of Variation 24.9 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 3.04 ng*h/mL | Geometric Coefficient of Variation 43.3 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.0524 ng*h/mL | Geometric Coefficient of Variation 82.5 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.906 ng*h/mL | Geometric Coefficient of Variation 42.8 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 4.06 ng*h/mL | Geometric Coefficient of Variation 42.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.108 ng*h/mL | Geometric Coefficient of Variation 45.5 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 3.28 ng*h/mL | Geometric Coefficient of Variation 36.2 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.138 ng*h/mL | Geometric Coefficient of Variation 79.5 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 1.40 ng*h/mL | Geometric Coefficient of Variation 32 |
Primary
AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Number analyzed is the number of participants with data available for analysis for the specified category. Data was not collected for AP32914 as no participant displayed a sufficient PK profile with respect to this parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 3.26 ng*h/mL | Geometric Coefficient of Variation 42.6 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 1.32 ng*h/mL | Geometric Coefficient of Variation 28.4 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 4.31 ng*h/mL | Geometric Coefficient of Variation 42.4 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 1.48 ng*h/mL | Geometric Coefficient of Variation 28.5 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 3.50 ng*h/mL | Geometric Coefficient of Variation 34.9 |
| Normal Hepatic Function: Mobocertinib 40 mg | AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 1.60 ng*h/mL | Geometric Coefficient of Variation 29.3 |
Primary
CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib | 195 liters per hour (L/hour) | Geometric Coefficient of Variation 32.7 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib | 137 liters per hour (L/hour) | Geometric Coefficient of Variation 48.9 |
| Normal Hepatic Function: Mobocertinib 40 mg | CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib | 201 liters per hour (L/hour) | Geometric Coefficient of Variation 36.2 |
Primary
CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib | 12300 L/hour | Geometric Coefficient of Variation 42.6 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib | 9290 L/hour | Geometric Coefficient of Variation 42.4 |
| Normal Hepatic Function: Mobocertinib 40 mg | CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib | 11400 L/hour | Geometric Coefficient of Variation 34.9 |
Primary
Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: Pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 3.88 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 28.8 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 9.67 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 58.2 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.752 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 38.6 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 2.82 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 27.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 11.3 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 31.7 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.722 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 32.5 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 10.5 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 37.6 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 1.15 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 31.7 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 4.80 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 23.6 |
Primary
Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0569 ng/mL | Geometric Coefficient of Variation 24.4 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.153 ng/mL | Geometric Coefficient of Variation 51.2 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.00518 ng/mL | Geometric Coefficient of Variation 81.3 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0396 ng/mL | Geometric Coefficient of Variation 35.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.167 ng/mL | Geometric Coefficient of Variation 50.3 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.00837 ng/mL | Geometric Coefficient of Variation 28.9 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.184 ng/mL | Geometric Coefficient of Variation 39.7 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 0.0127 ng/mL | Geometric Coefficient of Variation 36.1 |
| Normal Hepatic Function: Mobocertinib 40 mg | Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0729 ng/mL | Geometric Coefficient of Variation 22.2 |
Primary
t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Number analyzed is the number of participants with data available for analysis for the specified category. Data was not collected for AP32914 as no participant displayed a sufficient PK profile with respect to this parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 26.4 hours | Geometric Coefficient of Variation 16.8 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 31.7 hours | Geometric Coefficient of Variation 36.2 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 30.7 hours | Geometric Coefficient of Variation 20.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 45.0 hours | Geometric Coefficient of Variation 44.9 |
| Normal Hepatic Function: Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 22.9 hours | Geometric Coefficient of Variation 28.1 |
| Normal Hepatic Function: Mobocertinib 40 mg | t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 25.9 hours | Geometric Coefficient of Variation 29.1 |
Primary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 2.00 hours (h) |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 2.00 hours (h) |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 5.00 hours (h) |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 4.00 hours (h) |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 4.00 hours (h) |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 4.00 hours (h) |
| Normal Hepatic Function: Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 6.00 hours (h) |
| Normal Hepatic Function: Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 6.00 hours (h) |
| Normal Hepatic Function: Mobocertinib 40 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 6.00 hours (h) |
Primary
Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 7400 liters | Geometric Coefficient of Variation 30.5 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 6090 liters | Geometric Coefficient of Variation 30.7 |
| Normal Hepatic Function: Mobocertinib 40 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 6640 liters | Geometric Coefficient of Variation 37.7 |
Primary
Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 467000 liters | Geometric Coefficient of Variation 34.3 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 412000 liters | Geometric Coefficient of Variation 22.6 |
| Normal Hepatic Function: Mobocertinib 40 mg | Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib | 377000 liters | Geometric Coefficient of Variation 24.9 |
Primary
λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a plasma concentration against time curve.
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Number analyzed is the number of participants with data available for analysis for the specified category. Data was not collected for AP32914 as no participant displayed a sufficient PK profile with respect to this parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.0263 1/hour | Geometric Coefficient of Variation 16.8 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0218 1/hour | Geometric Coefficient of Variation 36.2 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.0226 1/hour | Geometric Coefficient of Variation 20.9 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0154 1/hour | Geometric Coefficient of Variation 44.9 |
| Normal Hepatic Function: Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 0.0303 1/hour | Geometric Coefficient of Variation 28.1 |
| Normal Hepatic Function: Mobocertinib 40 mg | λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 0.0268 1/hour | Geometric Coefficient of Variation 29.1 |
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Baseline up to 30 days after last dose of study drug (up to Day 32)
Population: Safety set included all participants who received the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 1 Participants |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 0 Participants |
| Normal Hepatic Function: Mobocertinib 40 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
Secondary
Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Time frame: Day 1 at multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 98.5 percentage bound | Standard Deviation 0.114 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 98.4 percentage bound | Standard Deviation 0.385 |
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 99.2 percentage bound | Standard Deviation 0.332 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 98.6 percentage bound | Standard Deviation 0.321 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 98.5 percentage bound | Standard Deviation 0.397 |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 98.7 percentage bound | Standard Deviation 0.621 |
| Normal Hepatic Function: Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | Mobocertinib | 98.2 percentage bound | Standard Deviation 0.426 |
| Normal Hepatic Function: Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32914 | 98.9 percentage bound | Standard Deviation 0.245 |
| Normal Hepatic Function: Mobocertinib 40 mg | Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914) | AP32960 | 98.5 percentage bound | Standard Deviation 0.129 |