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Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT04108676
Recruitment Status : Active, not recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
The Third Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Fluzoparib Drug: Omeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib
Masking: None (Open Label)
Primary Purpose: Other
Official Title: a Single-center, One-arm, Open, and Fixed Sequences Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy Male Volunteers
Actual Study Start Date : September 7, 2019
Actual Primary Completion Date : September 18, 2019
Estimated Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm
Drug: Fluzoparib Drug: Omeprazole
Drug: Fluzoparib
PARP inhibitor

Drug: Omeprazole
proton pump inhibitor




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Fluzoparib: [ Time Frame: through study completion, up to 24 weeks ]
    Cmax

  2. Area Under the Plasma Concentration-Time Curve From 0 to t of Fluzoparib: [ Time Frame: through study completion, up to 24 weeks ]
    AUC0-t

  3. Area Under the Plasma Concentration-Time Curve From 0 to infinity of Fluzoparib: [ Time Frame: through study completion, up to 24 weeks ]
    AUC0-∞ (if available)


Secondary Outcome Measures :
  1. Safety in terms of Adverse Events Assessments [ Time Frame: through study completion, up to 24 weeks ]
    Adverse Events Assessments (NCI-CTC AE 5.0)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. 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
  3. Those who have undergone surgery within 4 weeks prior to the trial or who plan to undergo surgery during the study;
  4. Those who have taken any drugs or health care products (including Chinese herbal medicines) within 14 days before the test;
  5. 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;
  6. Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial;
  7. Donate blood or massive blood loss (≥200 mL), receive blood transfusion or use blood products within 3 months before enrollment;
  8. One or more non-pharmaceutical contraceptives cannot be used during the volunteer trial;
  9. Those who have special requirements for diet and cannot follow the unified diet;
  10. Drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day;
  11. 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;
  12. 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;
  13. 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
  14. 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);
  15. have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
  16. Those who have undergone any surgery within the first 6 months of screening; have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction surgery, etc.);
  17. The volunteer refused to discontinue any beverage containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any juice, 48 hours before the study drug was administered until the end of the study;
  18. Creatinine clearance (CLCr) <80 mL/min, or creatinine above the upper limit of normal;
  19. Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108676


Locations
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China, Hunan
The third xiangya hospital Hospital,of central south university
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
The Third Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Guoping Yang, PhD The Third Xiangya Hospital of Central South University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04108676     History of Changes
Other Study ID Numbers: FZPL-I-111
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action