Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function

Healthy Subjects Clinical Trial

Official title:

A Open, Single-dose, Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694365
• Other study ID #: SHR3162-I-117
• Status: Recruiting
• Phase: Phase 1
• Start date: November 6, 2020
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuya Wang
• Phone: 13918749176
• Email: Wangyuya[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for subjects with impaired liver function:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;

2. Ability to complete the study as required by the protocol;

3. Healthy male or female subjects aged 18 to 65 (including 18 and 45) at the date of signing the informed consent;

4. Male body weight = 50 kg, female body weight = 45 kg, and body mass index (BMI) within the range of 19 ~ 29kg /m2 (including 19 and 29);

5. Participants with alcoholic liver disease, autoimmune liver disease, Non-Alcoholic Liver Diseases and inherited metabolic liver disease. Mild Hepatic Impairment group should be stable=28days ; Moderate Hepatic Impairment group should be stable=14days.

Exclusion Criteria impaired liver function:

1. Allergic constitution;

2. History of drug use, or drug abuse screening positive;

3. Alcoholic or often drinkers;

4. Received any surgery in the previous 6 months before screen phase;

5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal sysem.

6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

7. Patients with hepatic encephalopathy;

8. Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,

Inclusion Criteria for subjects with normal liver function:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;

2. Ability to complete the study as required by the protocol;

3. Healthy male or female subjects aged 18 to 65 (including 18 and 45) at the date of signing the informed consent;The age and gender should match with impaired liver function;

4. Male body weight = 50 kg, female body weight = 45 kg, and body mass index (BMI) within the range of 19 ~ 29kg /m2 (including 19 and 29); The body weight should match with impaired liver function.

Exclusion Criteria normal liver function:

1. Allergic constitution;

2. History of drug use, or drug abuse screening positive;

3. Alcoholic or often drinkers;

4. Received any surgery in the previous 6 months before screen phase;

5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal sysem.

6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

7. Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,

Related Conditions & MeSH terms

• Healthy Subjects
• Hepatic Impairment

Intervention

Drug:
• Fluzoparib
A single oral dose of 50 mg Fluzoparib will be administered.

Locations

Country	Name	City	State
China	Henan Infectious Diseases Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters of Fluzoparib: Cmax		through study completion, an averange of half year
Primary	Pharmacokinetics parameters of Fluzoparib: AUC0-t		through study completion, an averange of half year
Primary	Pharmacokinetics parameters of Fluzoparib: AUC0-8(if available)		through study completion, an averange of half year
Secondary	Other pharmacokinetics parameters of Fluzoparib: Tmax		through study completion, an averange of half year
Secondary	plasma protein binding rate of Fluzoparib		through study completion, an averange of half year
Secondary	The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)		through study completion, an averange of half year
Secondary	Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.		through study completion, an averange of half year