To Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Alkotinib Capsules in Healthy Subjects

NCT04032821 | Completed Phase 1

• 1 other identifier: ZGALK003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of food to Alkotinib Capsules in healthy subjects

Conditions

NSCLC

Keywords

Pharmacokinetics; Alkotinib

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum blood concentration

  up to 120 hours

• AUC0-t

  Area under the plasma concentration - time curve from 0 to the last measurable concentration time point t

  up to 120 hours

• AUC0-∞

  Area under the concentration - time curve from zero to infinity

  up to 6 months

Secondary Outcomes (5)

• Tmax

  up to 6 months

• t1/2

  up to 6 months

• λz

  up to 6 months

• CL/F

  up to 6 months

• VZ/F

  up to 6 months

Study Arms (2)

Alkotinib（300mg）First empty stomach, after the meal

EXPERIMENTAL

Alkotinib（300mg），Subjects need to be fasting overnight for at least 10 hours before being warmed to 240 mL on an empty stomach Water service, lunch 4 hours later, dinner 10 hours later.

Drug: Alkotinib（300mg)

Alkotinib（300mg）After eating first, after fasting

EXPERIMENTAL

Alkotinib（300mg），Subjects need to be fasting for at least 10 hours overnight, starting 30 min before taking the medication A standard meal (800-1000 CAL) can be taken before taking the medicine, and 240 mL warm water can be taken after the meal Lunch hours later, dinner 10 hours later.

Drug: Alkotinib（300mg)

Interventions

Alkotinib（300mg) DRUG

1\. First empty stomach, after the meal.2. After eating first, after fasting.

Alkotinib（300mg）After eating first, after fasting; Alkotinib（300mg）First empty stomach, after the meal

Eligibility Criteria

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

You may qualify if:

• sign the informed consent before the clinicaltrial, and fully understand the clinicaltrial content, process and possible adverse event.
• Be able to complete the research according to the clinicaltrial protocol.
• Subjects (including sexual partners) were willing to be screened up to 6 months after the last study drug administration No family planning and voluntary effective contraceptive measures, the specific contraceptive measures see appendix.
• Male and female subjects aged 18 to 55 years (including 18 and 55 years).
• The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. The body of the Body mass index (BMI) = weight (kg)/height 2 (m2), with a BMI of 18\~28 kg/m2 range (including critical value).
• Normal or abnormal physical examination and vital signs have n
• clinical significance.

You may not qualify if:

• Smoking more than 5 cigarettes per day during the first 3 months of the study
• Allergic constitution (multiple drug and food allergies).
• A history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = beer 285)ML, or liquor 25 mL, or wine 100 mL)
• Blood donation or massive blood loss within 3 months prior to clinical trial screening (\> 450ml)
• Any drugs that alter liver enzyme activity were taken 28 days before screening.
• Within 14 days prior to screening，took any prescription, over-the-counter, vitamin products or Herbs.
• Special diet (including dragon fruit, mango, grapefruit, etc.) or drama in 2 weeks，before screening strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
• CYP3A inhibitors (e.g., atanavir, talymycin, clarithromycin, etc.), CYP3A inducers (e.g Drugs metabolized by CYP2C8 (such as amodiaquine, silvastatin, etc.) and CYP2C9 metabolism Drugs such as diclofenac, ibuprofen, etc.
• There have been major changes in diet or exercise habits recently.
• Have taken a study drug or participated in a clinical trial of the drug within three months prior to taking the study drug Check.
• A history of dysphagia or any gastrointestinal illness that affects drug absorption, cholecystitis or cholecystectomy In addition to the history;
• Any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenum Ulcer etc.
• Subjects who could not tolerate standard meals
• Abnormal ecg has clinical significance, or QTc interval \>450 ms, or heart rate or pulse \< 55 times /Points.
• Any pulmonary disease, including but not limited to interstitial pneumonia, allergic pneumonia, occlusion.Bronchiolitis, pulmonary interstitial fibrosis,interstitial lung disease (ILD), or any pre-existing disease History.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The first Bethune hospital of jilin university

Changchun, Jilin, 130021, China

Location

Study Officials

• yanhua Ding, MD

  The First Hospital of Jilin University

  STUDY CHAIR

Study Design

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

Model Details: Each subject was randomly given Alkotinib capsules on an empty stomach or after a meal, and the cleaning period between the two dosages was set as 14 days. The actual dosing time was subject to the original clinical records. After admission to the ward on day -1 (1 day before drug administration), subjects will eat light dinner A 1:1 ratio was randomly assigned to 2 sequences (1=AB, 2=BA). Each subject was subject to two cycles of trials, and the study drug was taken once on an empty stomach or after meal according to the dosing sequence in the randomization table.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: November 20, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: April 12, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)