Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects

NCT04108676 | Completed Phase 1

• 1 other identifier: FZPL-I-111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

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 to 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-∞ (if available)

  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

EXPERIMENTAL

Drug: Fluzoparib Drug: Omeprazole

Drug: Fluzoparib; Drug: Omeprazole

Interventions

Fluzoparib DRUG

PARP inhibitor

single arm

Omeprazole DRUG

proton pump inhibitor

single arm

Eligibility Criteria

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

You may qualify if:

• Age 18 to 50 years (including both ends), male;
• Male volunteers have a body weight ≥ 50.0 kg and a body mass index (BMI) between 19 and 28 kg/m2 (including both ends);
• Male volunteers are willing to have no birth plans in the next 6 months and voluntarily take effective contraceptive measures;
• Volunteers voluntarily sign written informed consent.

You may not qualify if:

• Previous or currently suffering from circulatory system (myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.), endocrine system, nervous system, digestive system (peptic ulcer, colitis, pancreatitis, etc.), respiratory system (Invasive lung disease, pneumonia, dyspnea, etc., urogenital system (chronic kidney disease, renal insufficiency, renal anemia), hematology, immunology, psychiatry and metabolic abnormalities, etc. Result of any other disease;
• A history of allergies to drugs, foods or other substances; allergies, including a history of severe drug allergies or drug allergies; a history of allergies to Fluzoparib capsules or omeprazole magnesium enteric-coated tablets
• Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study;
• Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test;
• Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines;
• Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial;
• Donate blood or massive blood loss (≥200 mL), receive blood transfusion or use blood products within 3 months before enrollment;
• One or more non-pharmaceutical contraceptives cannot be used during the volunteer trial;
• Those who have special requirements for diet and cannot follow the unified diet;
• Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day;
• smokers or smokers with more than 5 cigarettes per day for the first 3 months of the trial or who cannot stop using any tobacco products during the trial period;
• Alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or during the test period Stop using any alcoholic products;
• Drug abusers or soft drugs (eg marijuana) 3 months prior to the trial or hard drugs (eg cocaine, phencyclidine, etc.) 1 year prior to the trial; and nicotinic positive volunteers
• Abnormal vital signs (systolic blood pressure \<90 mmHg or \>140 mmHg, diastolic blood pressure \<50 mmHg or \>90 mmHg; pulse \<50 bpm or \>100 bpm) or physical examination, electrocardiogram, laboratory examination, imaging examination abnormalities Clinically significant (subject to the judgment of the clinical research doctor);
• have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The third xiangya hospital Hospital,of central south university

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 9.

  PMID: 33420642 DERIVED

MeSH Terms

Interventions

fluzoparib; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guoping Yang, PhD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 30, 2019
• Study Start: September 7, 2019
• Primary Completion: September 18, 2019
• Study Completion: November 18, 2019
• Last Updated: July 29, 2022

Record last verified: 2021-09

Locations

CN (1)