Effect of Fluconazole on PK of Fluzoparib in Healthy Male Subjects

NCT04193319 | Completed Phase 1

• 1 other identifier: FZPL-I-108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the Effect of fluconazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration(Cmax) of Fluzoparib

  Cmax

  through study completion，up to 24 weeks

• Area under the Plasma Concentration-time curve From 0-t of Fluzoparib

  AUC0-t

  through study completion，up to 24 weeks

• Area under the Plasma Concentration-time curve From 0 to infinity of Fluzoparib

  AUC0-∞

  through study completion，up to 24 weeks

Secondary Outcomes (1)

• Safety in terms of Adverse Events Assessments

  through study completion，up to 24 weeks

Study Arms (1)

Single arm

OTHER

Drug: Fluzoparib; Drug: Fluconazole

Interventions

Fluzoparib DRUG

PARP inhibitor

Single arm

Fluconazole DRUG

inhibitor

Single arm

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 35- 50 years old (including both ends), male;
• The body weight is not less than 50 kg, and the body mass index \[BMI = weight kg / (height m) 2\] is in the range of 18 to 28 (including the critical value);
• Subjects are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
• Good health, no history of heart, liver, kidney, digestive tract, nervous system and metabolic abnormalities;
• There are no abnormalities or abnormalities in vital signs and physical examination.
• Understand the research procedures and methods, voluntarily participate in the trial, and sign the informed consent in writing. Fully understand the test content, process and possible adverse reactions;
• Creatinine is less than or equal to the upper limit of normal;

You may not qualify if:

• Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, participate in blood donation within one month and donate blood volume ≥200mL or blood loss ≥200mL, or receive blood transfusion;
• Allergies, including a history of severe drug allergies or drug allergies; a history of allergies to fluzolidine capsules or their excipients.
• Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have used drug abuse in the past five years or who have used drugs three months before the test;
• People who smoke alcohol (drinking 14 units of alcohol per week: 1 unit = beer 285 mL, or spirits 25 mL, or wine 100 mL; daily smoking ≥ 5) and can not be smoke-free and alcohol-free during the test period ;
• Those with previous history of cardiovascular disease such as cardiac insufficiency, myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
• Pulmonary diseases, including invasive lung disease, pneumonia, difficulty breathing, etc.;
• History of chronic kidney disease, renal insufficiency, and renal anemia;
• Have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
• Any uncontrolled peptic ulcer, inflammatory bowel disease, pancreatitis, etc.;
• Anyone who has undergone any surgery within the first 6 months of screening; has undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction, etc.)
• A clear history of other major organ diseases such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system within the first month prior to screening (eg uncontrolled diabetes, hypertension) Etc.), making the researcher feel unsuitable for participation in the study;
• Hepatotoxic drugs (such as acetaminophen, statin lipid-lowering drugs, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, etc. within 6 months prior to screening (for more than 2 consecutive weeks) Li Fuping);
• Those who have taken any clinical trial drug within 3 months;
• Take any medication that alters liver enzyme activity 28 days prior to taking the study drug (see Appendix 1);
• Take any prescription or over-the-counter medication 14 days before taking the study drug;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Hunan Cancer Hospital: collaborator

Study Sites (1)

Early Cancer Research Center of Hunan Cancer Hospital

Hunan, Hunan, 410013, China

Location

MeSH Terms

Interventions

fluzoparib; Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: November 21, 2019
• First Posted: December 10, 2019
• Study Start: July 19, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-11

Locations

CN (1)