Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects

NCT04360915 | Completed Phase 1

• 1 other identifier: ASK-LC-120067-Ib
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.

Conditions

Locally Advanced or Metastatic NSCLC

Outcome Measures

Primary Outcomes (2)

• Cmax

  Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out maximum concentration

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

• AUC

  Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out area under the plasma concentration-time curve

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

Secondary Outcomes (6)

• Tmax

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

• t1/2

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

• CL/F

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

• Vd/F

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

• λz

  Blood samples will be collected from each subject at pre-specified times after the administration of the study on Day 1, (pre-dose, 0.25h,0.5h, 1h,1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h,36h,48h,72 hours post dose)

Study Arms (2)

ASK120067 in fast condition

EXPERIMENTAL

Take ASK120067 tablets orally once in the first day at 160mg in fast condition.

Drug: ASK120067

ASK120067 in fed condition

EXPERIMENTAL

Take ASK120067 tablets orally once in the first day at 160mg in fed condition.

Dietary Supplement: ASK120067 in fed condition

Interventions

ASK120067 DRUG

Take ASK120067 tablets orally in first day at 160 mg in fast condition.

ASK120067 in fast condition

ASK120067 in fed condition DIETARY_SUPPLEMENT

Take ASK120067 tablets orally in first day at 160 mg in fed condition.

ASK120067 in fed condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Healthy subjects aged 18 or above and 45 or below, male and female;
• \) The weight of male subjects shall not be less than 50 kg, and that of female subjects shall not be less than 45 kg.Body mass index (BMI) = weight (kg)/height2 (m2), BMI = Within the range of 19.0\~26.0 (including the critical value);
• \) Normal or abnormal physical examination (physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, frontal and lateral chest radiographs, etc.) during the screening period has no clinical significance;
• \) Subjects (including male subjects) are willing to have no pregnancy plan from the screening date to 6 months after the last dose, and are willing to take effective contraceptive measures;
• \) Subjects should sign the informed consent before the test, fully understand the test content, process and possible adverse reactions, have good communication with researchers and complete the test according to the test plan.

You may not qualify if:

• \) patients with clinical significance who are abnormal by comprehensive physical examination, vital signs examination, routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, and positive and lateral chest radiographs;
• \) HBSAg HCVAb HIVAb, treponema palliatum antibody and other test results were positive;
• \) QTc interphase abnormality (QTc\>450ms) with clinical significance;
• \) participated in the drug clinical trial within 3 months before the trial;
• \) taking any medication 14 days before the trial;
• \) surgical resection history, such as: hepatectomy, nephrectomy, digestive organ (gallbladder) resection;
• \) history of tuberculosis;
• \) past history of deep vein thrombosis/other thromboembolic events, abnormal coagulation factors, thrombocytopenia, or abnormal platelet function;
• \) previous history of interstitial lung disease (ILD), drug-induced ILD, radioactive pneumonia requiring steroid treatment, or clinically active ILD with evidence;
• \) allergic or hypersensitive to ASK120067 experimental active ingredients or inactive excipients, drugs with similar chemical structure to the experimental drugs or drugs with the same target, allergic to two or more drugs and food;
• \) there are swallowing difficulties or gastrointestinal diseases affecting drug absorption;
• \) have any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers;
• \) habitual constipation or diarrhea;
• \) heavy drinking and/or a history of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• \) alcohol breath test \> 0.0mg /100mL;

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zourong Ruan

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

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 20, 2020
• First Posted: April 24, 2020
• Study Start: December 9, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

CN (1)