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Healthy Male VolunteersPhase 1NCT03926182

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

A Phase 1 study testing AST2818 Tablets in people with Healthy Male Volunteers, run by Allist Pharmaceuticals, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Male Volunteers
What is being tested?
AST2818 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
19 Feb 2019to 3 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • The participants who have history of needlesickness and blood phobia, and those with severe bleeding tendency.
  • The participants who cannot comply with the roles of unified diet.
  • The participants who cannot tolerate blood collection through venipuncture.
  • 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 );
  • Any intake of drink or food, enriched in xanthine and grapefruit, that could affect the drug's absorption, distribution, metabolism and excretion.
  • Any factors judged by investigator that the participants cannot meet.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Provincial Tumor Hospital

    Changsha, Hunan, 410013

Other trials in China

About this study

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

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

Read the 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).

Being tested
AST2818 Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AST2818 TabletsDrug

    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.

  • AST2818 TabletsDrug

    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 groups in NCT03926182
Study groupRoleWhat they receive
Fasted AST2818 tablets following a period of fastingExperimentalNot described
Receives: Drug: AST2818 Tablets
High-fat meal AST2818 tablets following a high-fat mealExperimentalNot described
Receives: Drug: AST2818 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of AST2818

    Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.

    Measured: 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.

  2. AUC(0-t) of AST2818

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

    Measured: 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.

  3. Tmax of AST2818

    Pharmacokinetics of AST2818 by assessment of time to Cmax.

    Measured: 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)

  1. Cmax of AST5902

    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of maximum plasma AST5902 concentration.

    Measured: 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.

  2. AUC(0-t) of AST5902

    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of area under the plasma

    Measured: 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.

  3. Tmax of AST5902

    Pharmacokinetics of AST5902 (metabolite to AST2818) by assessment of time to Cmax.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start19 Feb 2019
  3. Primary completion3 Apr 2019
  4. Study completion3 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926182
Sponsor's protocol ID
20190120
Status last verified
Jan 2020
First submitted
23 Apr 2019
Last updated
6 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AST2818 Tablets in people with Healthy Male Volunteers, run by Allist Pharmaceuticals, Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.

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