The Study to Assess the Pharmacokinetics of Pimicotinib i... | NCT06562946

Status Module

Oversight Module

Description 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
The mild (Child-Pugh score 5 to 6) hepatic impairment.	Experimental	Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib
The moderate (Child-Pugh score 7 to 9) hepatic impairment.	Experimental	Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib
The healthy subjects.	Experimental	Subjects will enter the study site on Day -1 and will remain there until after the collection of the 48 h PK samples on Day 3. On Day 1 all participants will receive a single 25 mg oral dose of pimicotinib under fasting conditions, followed by extensive blood collection and urine sample collection for measurement of pimicotinib and its metabolites.	Drug: Pimicotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimicotinib	Drug	Pimicotinib is supplied as capsules for oral use with a strength of 25 mg/capsule.	The healthy subjects. The mild (Child-Pugh score 5 to 6) hepatic impairment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUClast	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
AUC 0-∞	To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects.	Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol

Eligibility Module

Name	Affiliation	Role
Yanan Wang, Doctor	The First Hospital of Jilin University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The first hospital of Jilin University		Changchun	Jilin		China

IPD Sharing Statement Module