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Effect of Fluconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04850651
Recruitment Status : Completed
First Posted : April 20, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
The primary objective of the study is to evaluate the effect of fluconazole on pharmacokinetics of pyrotinib tablet for oral administration in healthy Chinese adult subjects. The secondary objective of the study is to compare the safety of pyrotinib alone and co-administered with fluconazole.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Pyrotinib；Fluconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pyrotinib alone and then combination with fluconazole
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Pyrotinib in Healthy Chinese Adult Subjects.
Actual Study Start Date : April 16, 2021
Actual Primary Completion Date : May 17, 2021
Actual Study Completion Date : May 17, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pyrotinib/Fluconazole
Durg: Pyrotinib Durg: Pyrotinib/Fluconazole Participants received a single oral dose of pyrotinib 80 milligram (mg) on day1 and day9. Participants received a loading dose of fluconazole 400 mg on day6 followed by single dose of fluconazole 200 mg for oral administration from D7 to D18.
 Drug: Pyrotinib；Fluconazole

Drug: Pyrotinib Participants received a single oral dose of Pyrotinib tablet on the morning of day1 in treatment period 1.

Drug: Pyrotinib/Fluconazole In treatment period 2, Participants received a single oral dose of pyrotinib tablet on the morning of day9, and received a loading dose of fluconazole capsule on day6 followed by single dose of fluconazole for oral administration from D7 to D18.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Pyrotinib [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 (Combined with Fluconazole), 240 (Combined with Fluconazole) Hours Post-dose ]
  2. Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of Pyrotinib [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 (Combined with Fluconazole), 240 (Combined with Fluconazole) Hours Post-dose ]
  3. Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-Inf) of Pyrotinib [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 (Combined with Fluconazole), 240 (Combined with Fluconazole) Hours Post-dose ]
    AUC0-inf was defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).


Secondary Outcome Measures :
  1. The Time Take to Reach Cmax (Tmax) of Pyrotinib [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 (Combined with Fluconazole), 240 (Combined with Fluconazole) Hours Post-dose ]
  2. Elimination Half Life (t1/2) of Pyrotinib [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 (Combined with Fluconazole), 240 (Combined with Fluconazole) Hours Post-dose ]
    Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.

  3. The Incidence and Severity of Adverse Events (AEs) or Serious Adverse Events (SAEs) in Participants [ Time Frame: Baseline up to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants has given written informed consent with full understanding of the trial content, process and possible adverse reactions;
  2. Ability to complete the study as required by the protocol;
  3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
  4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
  5. Willing to take contraception or male subjects who can guarantee not to donate sperm during the trial and within 6 months after the last dose; female subjects with fertility who did not use contraception for at least 2 weeks before dosing;

Exclusion Criteria:

  1. Allergic constitution or Allergic to a drug ingredient or component;
  2. History of drug use, or drug abuse screening positive;
  3. Alcoholic or often drinkers;
  4. Left ventricular ejection fraction (LVEF) <50% by echocardiography;
  5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system;
  6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;
  7. Participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study;
  8. Positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
  9. Blood loss ≥400mL within 3 months before first dosing;
  10. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
  11. The investigators determined that other conditions were inappropriate for participation in this clinical trial .
Contacts and Locations
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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): NCT04850651


Locations
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China, Shandong
Jinan Central Hospital
Jinan, Shandong, China, 250013
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04850651    
Other Study ID Numbers: HR-BLTN-DDI-06
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors