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出境医 / 临床实验 / Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers

Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers

Study Description
Brief Summary:
To assess the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers in Fasting State or Following a High Fat Meal

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: AST2818 Tablets Phase 1

Detailed Description:
This is a single center, randomized, open label, single dose, two periods crossover study in healthy male volunteers. The volunteers will be randomly distributed into two groups (fasted-fed and fed-fasted groups). Any volunteer will be administrated once in each treatment period, the interval time of two treatment periods is 22 days (the interval time is no longer than 30 days).
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Center, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Volunteers in the Fasted State or Following a High Fat Meal
Actual Study Start Date : February 19, 2019
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Fasted AST2818 tablets following a period of fasting Drug: AST2818 Tablets
AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
Experimental: High-fat meal AST2818 tablets following a high-fat meal Drug: AST2818 Tablets
AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.
Outcome Measures
Primary Outcome Measures :
  1. Cmax of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.

  2. AUC(0-t) of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time

  3. Tmax of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of time to Cmax.


Secondary Outcome Measures :
  1. Cmax of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of maximum plasma AST5902 concentration.

  2. AUC(0-t) of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of area under the plasma

  3. Tmax of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of time to Cmax.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male must be ≥ 18 and ≤ 55 years of age.
  2. Bodyweight of male must be ≥50.0kg and ≤80kg, and the Body Mass Index must be ≥19.0 and ≤26.0 kg/m2.
  3. The results of previous medical history in screening period, physical examination, vital signs, blood and urine routine examination, blood biochemistry, chest X-ray and ECG should compliance with the clinical protocol, or they will be recognized as non-clinical signs (NCS) if beyond the regulated range.
  4. The results of echocardiographic examination should meet the criteria that the LVEF value measured by biplane Simpson method was ≥ 50%.
  5. The participants must have no birthing plan and agree to take adequate non-drug contraceptive measures within the study to 4 months after the last drug treatment.
  6. The participants have good communications with investigators, understand and comply with all requirements and fully understand and sign the informed consent form.

Exclusion Criteria:

  1. The participants have history of chronic disease and serious illness in vascular system, blood system, urinary system, respiratory system, digestive system, nervous system, skin system and psychiatric disorders, any conditions and illness threat to the health of participants, and the history of hereditary disease.
  2. The participants have history of similar drug, allergy history to similar drug, allergic disorders and allergic constitution.
  3. The participants having history of drug abuse，opioid and tranquillizer， drug addicts, or drug screening for someone was positive.
  4. Resting corrected electrocardiogram QT interval using Fridericia's correction factor (QTcF) >470 msec within screening period.
  5. Any factors that increase the risk of prolonging QTc and abnormality in heart rate, i.e., heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or unreasonable sudden death at age smaller than 40 in first-degree relatives, administrating any combined medicines that possibly prolong QT interval
  6. Severe disease of respiratory system, i.e., interstitial lung disease and severe asthma, etc.
  7. Severe disease of ophthalmic system, e.g., corneal diseases;
  8. The participants have severe infection, severe trauma or major surgery within 1 year before screening;
  9. The participants 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, positive results of alcohol breath test and the volunteers who cannot give up drinking during study.
  10. The participants who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
  11. The participants who have blood donation or excessive bleeding(>200ml) 3 months prior to first dose, and planned to donate blood or blood constituent.
  12. The participants who were taking any prescription medicine、CYP3A4 inducers/inhibitors within 1 month prior to first dose; any OTC, health care products (including vitamins), traditional chinese medicine within 2 weeks prior to screening period.
  13. The participants who participated other clinical trials and took the investigational drug 3 months prior to first dose.
  14. The participants who have positive test result in HBsAg, Anti-HCV, Anti-HIV and TPPA.
  15. Any condition affecting the drug taking, or affecting the oral absorption, include any kind of severe chronic gastroenteropathy, history of gastrointestinal resection or surgery, uncontrollable nausea or vomit, disability in swallowing.
  16. The participants who have history of needlesickness and blood phobia, and those with severe bleeding tendency.
  17. The participants who cannot comply with the roles of unified diet.
  18. The participants who cannot tolerate blood collection through venipuncture.
  19. The participants who have chronic overconsumption (> 8 cup one day, 1 cup=250 ml) of tea, coffee, and the drink with caffeine; or intake food or drink consist of any caffeine (i.e., coffee, strong tea, and chocolate );
  20. Any intake of drink or food, enriched in xanthine and grapefruit, that could affect the drug's absorption, distribution, metabolism and excretion.
  21. Any factors judged by investigator that the participants cannot meet.
Contacts and Locations

Locations
Layout table for location information
China, Hunan
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Allist Pharmaceuticals, Inc.
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE February 19, 2019
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Cmax of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.
  • AUC(0-t) of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time
  • Tmax of AST2818 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST2818 by assessment of time to Cmax.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Cmax of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of maximum plasma AST5902 concentration.
  • AUC(0-t) of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of area under the plasma
  • Tmax of AST5902 [ Time Frame: Blood samples collected on Day 1 at 0.5 hour of pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, 504 hours post AST2818 dose in each period of two groups. ]
    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of time to Cmax.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers
Official Title  ICMJE A Randomized, Open Label, Single Center, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Volunteers in the Fasted State or Following a High Fat Meal
Brief Summary To assess the Effect of Food on the Blood Levels of AST2818 Following Single Oral Doses in Healthy Male Volunteers in Fasting State or Following a High Fat Meal
Detailed Description This is a single center, randomized, open label, single dose, two periods crossover study in healthy male volunteers. The volunteers will be randomly distributed into two groups (fasted-fed and fed-fasted groups). Any volunteer will be administrated once in each treatment period, the interval time of two treatment periods is 22 days (the interval time is no longer than 30 days).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Volunteers
Intervention  ICMJE
  • Drug: AST2818 Tablets
    AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
  • Drug: AST2818 Tablets
    AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.
Study Arms  ICMJE
  • Experimental: Fasted AST2818 tablets following a period of fasting
    Intervention: Drug: AST2818 Tablets
  • Experimental: High-fat meal AST2818 tablets following a high-fat meal
    Intervention: Drug: AST2818 Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 3, 2019
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male must be ≥ 18 and ≤ 55 years of age.
  2. Bodyweight of male must be ≥50.0kg and ≤80kg, and the Body Mass Index must be ≥19.0 and ≤26.0 kg/m2.
  3. The results of previous medical history in screening period, physical examination, vital signs, blood and urine routine examination, blood biochemistry, chest X-ray and ECG should compliance with the clinical protocol, or they will be recognized as non-clinical signs (NCS) if beyond the regulated range.
  4. The results of echocardiographic examination should meet the criteria that the LVEF value measured by biplane Simpson method was ≥ 50%.
  5. The participants must have no birthing plan and agree to take adequate non-drug contraceptive measures within the study to 4 months after the last drug treatment.
  6. The participants have good communications with investigators, understand and comply with all requirements and fully understand and sign the informed consent form.

Exclusion Criteria:

  1. The participants have history of chronic disease and serious illness in vascular system, blood system, urinary system, respiratory system, digestive system, nervous system, skin system and psychiatric disorders, any conditions and illness threat to the health of participants, and the history of hereditary disease.
  2. The participants have history of similar drug, allergy history to similar drug, allergic disorders and allergic constitution.
  3. The participants having history of drug abuse，opioid and tranquillizer， drug addicts, or drug screening for someone was positive.
  4. Resting corrected electrocardiogram QT interval using Fridericia's correction factor (QTcF) >470 msec within screening period.
  5. Any factors that increase the risk of prolonging QTc and abnormality in heart rate, i.e., heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or unreasonable sudden death at age smaller than 40 in first-degree relatives, administrating any combined medicines that possibly prolong QT interval
  6. Severe disease of respiratory system, i.e., interstitial lung disease and severe asthma, etc.
  7. Severe disease of ophthalmic system, e.g., corneal diseases;
  8. The participants have severe infection, severe trauma or major surgery within 1 year before screening;
  9. The participants 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, positive results of alcohol breath test and the volunteers who cannot give up drinking during study.
  10. The participants who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
  11. The participants who have blood donation or excessive bleeding(>200ml) 3 months prior to first dose, and planned to donate blood or blood constituent.
  12. The participants who were taking any prescription medicine、CYP3A4 inducers/inhibitors within 1 month prior to first dose; any OTC, health care products (including vitamins), traditional chinese medicine within 2 weeks prior to screening period.
  13. The participants who participated other clinical trials and took the investigational drug 3 months prior to first dose.
  14. The participants who have positive test result in HBsAg, Anti-HCV, Anti-HIV and TPPA.
  15. Any condition affecting the drug taking, or affecting the oral absorption, include any kind of severe chronic gastroenteropathy, history of gastrointestinal resection or surgery, uncontrollable nausea or vomit, disability in swallowing.
  16. The participants who have history of needlesickness and blood phobia, and those with severe bleeding tendency.
  17. The participants who cannot comply with the roles of unified diet.
  18. The participants who cannot tolerate blood collection through venipuncture.
  19. The participants who have chronic overconsumption (> 8 cup one day, 1 cup=250 ml) of tea, coffee, and the drink with caffeine; or intake food or drink consist of any caffeine (i.e., coffee, strong tea, and chocolate );
  20. Any intake of drink or food, enriched in xanthine and grapefruit, that could affect the drug's absorption, distribution, metabolism and excretion.
  21. Any factors judged by investigator that the participants cannot meet.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926182
Other Study ID Numbers  ICMJE 20190120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allist Pharmaceuticals, Inc.
Study Sponsor  ICMJE Allist Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allist Pharmaceuticals, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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