A Study to Investigate the Effect of Impaired Hepatic Fun... | NCT04226833

NCT04226833

ID	Type	Description	Link
2019-003065-17	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild	Experimental	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.	Drug: entrectinib
Moderate	Experimental	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.	Drug: entrectinib
Severe	Experimental	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.	Drug: entrectinib
Normal	Experimental	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.	Drug: entrectinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
entrectinib	Drug	1x100 milligram (mg) capsule given with approximately 240 milliliter (mL) of water within 30 minutes of consumption of a standardized meal	Mild Moderate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Entrectinib	Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units	From Day 1 to Day 7
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Entrectinib		From Day 1 to Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Entrectinib		From Day 1 to Day 7
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib	First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units	From Day 1 to Day 7
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib		From Day 1 to Day 7
Apparent Terminal Elimination Rate Constant (Lz) of Entrectinib		From Day 1 to Day 7
Apparent Oral Clearance (CL/F) of Entrectinib	Obtained by dividing the total dose of parent drug by its corresponding AUCinf	From Day 1 to Day 7
The Apparent Volume of Distribution (Vz/F) of Entrectinib	Obtained by dividing Dose by the product of AUCinf and λz

Measure	Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE=adverse event TEAE=treatment-emergent adverse event	4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All participants:

A body mass index (BMI) between 18.0 and 38.0 kg/m2, and weighing at least 50 kg
Agreement to comply with measures to prevent pregnancy and restrictions on sperm donation.

Participants with normal hepatic function:

Normal hepatic function and no history of clinically significant hepatic dysfunction.
Healthy for age-group in the opinion of the Investigator.

Participants with hepatic impairment:

Mild, moderate or severe hepatic dysfunction (i.e. Child-Pugh A, B or C, NCIODWG Mild, Moderate or Severe) arising from cirrhosis of the liver as the result of parenchymal liver disease.
Stable hepatic function.

Exclusion Criteria:

Transjugular intrahepatic portosystemic shunt or other porta-caval shunt.
A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers.
Recent history or signs of severe hepatic encephalopathy (e.g., a portal systemic encephalopathy score >2).
Advanced ascites or ascites which require emptying and albumin supplementation.
Hepatocellular carcinoma, acute liver disease or serum ALT or AST not consistent with stable disease.
Recipient of a liver transplant.
Uncontrolled hypertension.
Clinically significant impairment of renal function.
A history of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract.
Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness.
Women who are pregnant or lactating.
Presence of any abnormal ECG finding, which is clinically significant.
Use of moderate or potent inhibitors or inducers of cytochrome P450 3A4 enzyme.
Participation in any other clinical study involving administration of an investigational medicinal product or use of an unapproved device.
A positive test result for human immunodeficiency virus (HIV).
Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds or other excipients in the entrectinib formulation.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pharmaceutical Research Associates CZ, s.r.o.		Prague		170 00	Czechia
CRU Hungary Kft

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39934586	Derived	Ozbey AC, Meneses-Lorente G, Simmons B, McCallum S, Annaert P, Parrott N, Umehara K. Clinical Exploration and Physiologically Based Modelling of the Impact of Hepatic Impairment on Entrectinib Pharmacokinetics. Clin Pharmacokinet. 2025 Mar;64(3):437-451. doi: 10.1007/s40262-024-01468-y. Epub 2025 Feb 11.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
FG001	Moderate

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 3, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
BG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
BG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
BG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG00112 BG00211 BG0038 BG00438

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.9± 8.86 BG00158.0± 9.49 BG00257.3± 10.08 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Observed Plasma Concentration (Cmax) of Entrectinib

Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Units	Counts
Participants	OG0007 OG00112 OG00211 OG003

Title

Denominators

Categories

Title	Measurements
	OG000296.140± 40.6 OG001213.570± 36.7 OG002183.680± 34.3 OG003

Secondary

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=adverse event TEAE=treatment-emergent adverse event

Posted

Number

Participants

4 weeks

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Entrectinib

Posted

Geometric Mean

Geometric Coefficient of Variation

h*nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Entrectinib

Posted

Geometric Mean

Geometric Coefficient of Variation

h*nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib

First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units

Posted

Median

Full Range

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Apparent Terminal Elimination Half-life (t1/2) of Entrectinib

Posted

Geometric Mean

Geometric Coefficient of Variation

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Apparent Terminal Elimination Rate Constant (Lz) of Entrectinib

Posted

Mean

Standard Deviation

1/h

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Apparent Oral Clearance (CL/F) of Entrectinib

Obtained by dividing the total dose of parent drug by its corresponding AUCinf

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/(h*nmol/L)

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

The Apparent Volume of Distribution (Vz/F) of Entrectinib

Obtained by dividing Dose by the product of AUCinf and λz

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/(nmol/L)

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Maximum Observed Plasma Concentration (Cmax) of M5

Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal

Primary

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of M5

Posted

Geometric Mean

Geometric Coefficient of Variation

h*nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of M5

Posted

Geometric Mean

Geometric Coefficient of Variation

h*nmol/L

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Time of Maximum Observed Plasma Concentration (Tmax) of M5

First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units

Posted

Median

Full Range

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Apparent Terminal Elimination Rate Constant (Lz) of M5

Posted

Mean

Standard Deviation

1/h

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Primary

Apparent Terminal Elimination Half-life (t1/2) of M5

Posted

Geometric Mean

Geometric Coefficient of Variation

From Day 1 to Day 7

ID	Title	Description
OG000	Mild	Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.
OG001	Moderate	Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG002	Severe	Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.
OG003	Normal	Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Entrectinib - Normal	Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.	0	8	0	8	2	8
EG001	Entrectinib Mild	Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.	0	7	0	7	0	7
EG002	Entrectinib Moderate	Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.	0	12	0	12	1	12
EG003	Entrectinib Severe	Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.	1	11	1	11	2	11

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Gastroenteritis	Infections and infestations		Systematic Assessment		EG0000 events0 affected8 at risk EG0010 events0 affected7 at risk EG0020 events0 affected12 at risk EG0031 events1 affected11 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected7 at risk EG0020 events0 affected12 at risk EG0030 events0 affected11 at risk
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected7 at risk EG0020 events0 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected7 at risk EG0021 events1 affected12 at risk EG003

ID	Term
D048550	Hepatic Insufficiency

ID	Term
C000607349	entrectinib

Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases