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

NCT04013048 | Completed Phase 1

• 1 other identifier: FZPL-I-107
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

Solid Tumor; 14C-Fluzoparib

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (1)

[14C]-Fluzoparib

EXPERIMENTAL

Patients will receive single dose of \[14C\]- Fluzoparib.

Drug: [14C]-Fluzoparib

Interventions

[14C]-Fluzoparib DRUG

Patients will receive single dose of orally \[14C\]- Fluzoparib on Day 1.

[14C]-Fluzoparib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who take any drugs that strongly inhibit or induce the CYP450 enzyme 14 days prior to study drug administration；
• 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；
• Subjects who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
• 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.
• 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.
• 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.
• Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial.
• 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.
• Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
• Subjects must not have had prior treatment with PARP inhibitors.
• Subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 9, 2019
• Study Start: July 8, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: July 31, 2020

Record last verified: 2019-07

Locations

CN (1)