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

NCT03926182 | Completed Phase 1

• 1 other identifier: 20190120
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (3)

• Cmax of AST2818

  Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.

  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.

• AUC(0-t) of AST2818

  Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time

  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.

• Tmax of AST2818

  Pharmacokinetics of AST2818 by assessment of time to Cmax.

  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.

Secondary Outcomes (3)

• Cmax of AST5902

  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.

• AUC(0-t) of AST5902

  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.

• Tmax of AST5902

  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.

Study Arms (2)

Fasted AST2818 tablets following a period of fasting

EXPERIMENTAL

Drug: AST2818 Tablets

High-fat meal AST2818 tablets following a high-fat meal

EXPERIMENTAL

Drug: AST2818 Tablets

Interventions

AST2818 Tablets DRUG

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.

Fasted AST2818 tablets following a period of fasting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male must be ≥ 18 and ≤ 55 years of age.
• Bodyweight of male must be ≥50.0kg and ≤80kg, and the Body Mass Index must be ≥19.0 and ≤26.0 kg/m2.
• 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.
• The results of echocardiographic examination should meet the criteria that the LVEF value measured by biplane Simpson method was ≥ 50%.
• 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.
• The participants have good communications with investigators, understand and comply with all requirements and fully understand and sign the informed consent form.

You may not qualify if:

• 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.
• The participants have history of similar drug, allergy history to similar drug, allergic disorders and allergic constitution.
• The participants having history of drug abuse，opioid and tranquillizer， drug addicts, or drug screening for someone was positive.
• Resting corrected electrocardiogram QT interval using Fridericia's correction factor (QTcF) \>470 msec within screening period.
• 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
• Severe disease of respiratory system, i.e., interstitial lung disease and severe asthma, etc.
• Severe disease of ophthalmic system, e.g., corneal diseases;
• The participants have severe infection, severe trauma or major surgery within 1 year before screening;
• 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.
• The participants who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
• The participants who have blood donation or excessive bleeding(\>200ml) 3 months prior to first dose, and planned to donate blood or blood constituent.
• 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.
• The participants who participated other clinical trials and took the investigational drug 3 months prior to first dose.
• The participants who have positive test result in HBsAg, Anti-HCV, Anti-HIV and TPPA.
• 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.

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

Hunan Provincial Tumor Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Interventions

aflutinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 24, 2019
• Study Start: February 19, 2019
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

CN (1)