Hepatic ImpairmentPhase 1NCT04056468

A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function

A Phase 1 study testing Mobocertinib in people with Hepatic Impairment and Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy Volunteers
What is being tested?: Mobocertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 9 Oct 2020to 26 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.
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.
Creatinine clearance (estimated glomerular filtration rate [eGFR]) >=60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.
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.
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.

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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.
Creatinine clearance (eGFR) >=60 mL/min/1.73 m^2 at screening.
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.

Who cannot join

Positive results for COVID-19 at screening or check in.
Seated blood pressure is less than 90/40 millimeters of Mercury (mmHg) or greater than 150/95 mmHg at screening.
Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
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.
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.
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.

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Donation of blood or had significant blood loss within 56 days prior to dosing.
Plasma donation within 7 days prior to dosing.
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function

Read the 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.

Conditions: Hepatic Impairment, Healthy Volunteers
Being tested: Mobocertinib
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MobocertinibDrug
Also called AP32788, TAK-788
Mobocertinib capsule.

Study groups in NCT04056468
Study group	Role	What they receive
Moderate HI (Child-Pugh B): Mobocertinib 40 mg	Experimental	Mobocertinib 40 milligram (mg), capsule, orally, a single dose on Day 1. Receives: Drug: Mobocertinib
Severe HI (Child-Pugh C): Mobocertinib 40 mg	Experimental	Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. Receives: Drug: Mobocertinib
Normal Hepatic Function: Mobocertinib 40 mg	Experimental	Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. Receives: Drug: Mobocertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
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.
Measured: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib
Measured: 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
Measured: 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
Measured: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib
Measured: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Secondary outcomes (2)

Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Measured: Day 1 at multiple time points (up to 24 hours) post-dose
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.
Measured: Baseline up to 30 days after last dose of study drug (up to Day 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 202026 Feb 2022

First posted14 Aug 2019
Study start9 Oct 2020
Primary completion5 Feb 2022
Study completion26 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04056468
Sponsor's protocol ID: TAK-788-1008
Other IDs: U1111-1236-7377
Status last verified: Jan 2023
First submitted: 13 Aug 2019
Last updated: 3 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function
ClinicalTrials.gov ID: NCT04056468
Acronym / sponsor ID: TAK-788-1008
Conditions: Hepatic Impairment, Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 9 Oct 2020 (actual)
Primary completion: 5 Feb 2022 (actual)
Study completion: 26 Feb 2022 (actual)
First posted: 14 Aug 2019 (actual)
Results: Posted 3 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Moderate HI (Child-Pugh B): Mobocertinib 40 mg
Severe HI (Child-Pugh C): Mobocertinib 40 mg
Normal Hepatic Function: Mobocertinib 40 mg

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Moderate HI (Child-Pugh B): Mobocertinib 40 mg	Experimental	Drug: MobocertinibMobocertinib 40 milligram (mg), capsule, orally, a single dose on Day 1.
Severe HI (Child-Pugh C): Mobocertinib 40 mg	Experimental	Drug: MobocertinibMobocertinib 40 mg, capsule, orally, a single dose on Day 1.
Normal Hepatic Function: Mobocertinib 40 mg	Experimental	Drug: MobocertinibMobocertinib 40 mg, capsule, orally, a single dose on Day 1.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
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.
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.
Creatinine clearance (estimated glomerular filtration rate [eGFR]) >=60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.
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.

Key exclusion criteria (9 listed)

Positive results for COVID-19 at screening or check in.
Seated blood pressure is less than 90/40 millimeters of Mercury (mmHg) or greater than 150/95 mmHg at screening.
Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MobocertinibAlso: AP32788, TAK-788Mobocertinib capsule.	Drug	Moderate HI (Child-Pugh B): Mobocertinib 40 mg, Normal Hepatic Function: Mobocertinib 40 mg, Severe HI (Child-Pugh C): Mobocertinib 40 mg

Primary outcome

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
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
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
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
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
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
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
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
λz: Terminal Elimination Rate Constant 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
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
Time frame: 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
Time frame: 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
Time frame: Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
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

2 secondary outcomes

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
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 30 days after last dose of study drug (up to Day 32)

Results and safety

Results posted to the registry on 3 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate HI (Child-Pugh B): Mobocertinib 40 mg	8	8
Severe HI (Child-Pugh C): Mobocertinib 40 mg	8	8
Normal Hepatic Function: Mobocertinib 40 mg	8	8

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Moderate HI (Child-Pugh B): Mobocertinib 40 mg n = 8	Severe HI (Child-Pugh C): Mobocertinib 40 mg n = 8	Normal Hepatic Function: Mobocertinib 40 mg n = 8
Mobocertinib	9.67 (58.2)	11.3 (31.7)	10.5 (37.6)
AP32960	3.88 (28.8)	2.82 (27.9)	4.80 (23.6)
AP32914	0.752 (38.6)	0.722 (32.5)	1.15 (31.7)

Population analysed: 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).

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Moderate HI (Child-Pugh B): Mobocertinib 40 mg n = 8	Severe HI (Child-Pugh C): Mobocertinib 40 mg n = 8	Normal Hepatic Function: Mobocertinib 40 mg n = 8
Mobocertinib	0.153 (51.2)	0.167 (50.3)	0.184 (39.7)
AP32960	0.0569 (24.4)	0.0396 (35.9)	0.0729 (22.2)
AP32914	0.00518 (81.3)	0.00837 (28.9)	0.0127 (36.1)

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hours/milliliters (ng*h/mL)

Measure	Moderate HI (Child-Pugh B): Mobocertinib 40 mg n = 8	Severe HI (Child-Pugh C): Mobocertinib 40 mg n = 8	Normal Hepatic Function: Mobocertinib 40 mg n = 8
Mobocertinib	206 (32.7)	291 (48.9)	199 (36.2)
AP32960	91.6 (22.2)	115 (1.94)	105 (31.5)

Population analysed: 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.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Moderate HI (Child-Pugh B): Mobocertinib 40 mg n = 8	Severe HI (Child-Pugh C): Mobocertinib 40 mg n = 8	Normal Hepatic Function: Mobocertinib 40 mg n = 8
Mobocertinib	3.26 (42.6)	4.31 (42.4)	3.50 (34.9)
AP32960	1.32 (28.4)	1.48 (28.5)	1.60 (29.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 30 days after last dose of study drug (up to Day 32). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate HI (Child-Pugh B): Mobocertinib 40 mg	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Severe HI (Child-Pugh C): Mobocertinib 40 mg	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Normal Hepatic Function: Mobocertinib 40 mg	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mobocertinib in people with Hepatic Impairment and Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04056468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.