Study to Evaluate the Mass Balance and Biotransformation of [14C]-Fluzoparib in Chinese Patients With Solid Tumor

A Phase I Mass Balance and Biotransformation Study of [14C]-Fluzoparib in Chinese Patients With Solid Tumor

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-FZPL in Chinese Patients with Solid Tumor

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: [14C]-Fluzoparib

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects diagnosed with advanced solid malignancies who are refractory or intolerant to standard therapy or considered to be benefit from the treatment of fluzoparib.
2. ECOG performance status of 0 to 1.
3. Life expectancy of more than 3 months.
4. Signing the informed consent forms.
5. Adequate bone marrow, liver and renal function.
6. Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.

Exclusion Criteria:

1. Subjects who take any drugs that strongly inhibit or induce the CYP450 enzyme 14 days prior to study drug administration；
2. Those who have history of alcohol abuse (it was defined as that the daily alcohol consumption was higher than the following criteria: the weekly alcohol consumption was higher than 14 units of alcohol (1 unit= 360 ml beers/45 ml liquor containing 40% alcohol/150ml grape wine) 6 months prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period；
3. Subjects who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
4. Subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive.
5. Subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test.
6. Subjects who need long-term exposure to radiation, or who have been exposed to PET-CT or ECT within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals.
7. Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial.
8. Subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial.
9. Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
10. Subjects must not have had prior treatment with PARP inhibitors.
11. Subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-Fluzoparib; Patients will receive single dose of [14C]- Fluzoparib.	Drug: [14C]-Fluzoparib; Patients will receive single dose of orally [14C]- Fluzoparib on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The distribution of Fluzoparib in the whole blood and plasma and whole.radioactive pharmacokinetics following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.	The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in blood and in total, up to Day 10 (approx).	Up to 10 days (approx) from the start of administration.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor to obtain the mass balance data and the main excretion pathway in human body.	The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in urine, faeces and in total, up to Day 10 (approx).	Up to 10 days (approx) from the start of administration.
Identification of the main metabolite and biotransformation pathway of Fluzoparib and investigation of metabolite with proportion >10% in plasma following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.	Proportion of different metabolites.	Up to 10 days (approx) from the start of administration.
Quantitive analysis of the concentrations of Fluzoparib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.	The concentrations of Fluzoparib in plasma up to Day 10.	Up to 10 days (approx) from the start of administration.
Observation of safety following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.	Adverse events assessed by CTCAE v5.0.	Up to 10 days (approx) from the start of administration.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): December 24, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Solid Tumor; 14C-Fluzoparib
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FZPL-I-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No