A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers

NCT04126668 | Completed Phase 1

• 1 other identifier: CM082-CA-I-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Peak plasma concentration (Cmax) of CM082

  The effect of food on Cmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

  pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)

• Area under the plasma concentration versus time curve (AUC) of CM082

  The effect of food on AUC after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

  pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)

• Time of maximum concentration（Tmax）of CM082

  The effect of food on Tmax after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

  pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)

• Half life（T1/2）of CM082

  The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

  pre-dose(30minute),30min、1、1.5、2、2.5、3、3.5、4、4.5、5、6、8、10、12、24、36、48、72hour (after administration)

Secondary Outcomes (1)

• Percentage of adverse events

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months

Study Arms (2)

Period 1: fasted control → Period 2: fed control

EXPERIMENTAL

Period 1: administration of CM082 200 mg at 7:30am, without the breakfast；Period 2: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast

Drug: CM082 with fed or fasting

Period 1: fed control → Period 2: fasted control

EXPERIMENTAL

Period 1: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast；Period 2: administration of CM082 200 mg at 7:30am, without the breakfast

Drug: CM082 with fed or fasting

Interventions

CM082 with fed or fasting DRUG

The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.

Period 1: fasted control → Period 2: fed control; Period 1: fed control → Period 2: fasted control

Eligibility Criteria

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

You may qualify if:

• age: 18 - 45 years;
• sex: male and female;
• body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
• Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
• Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available；
• Written informed consent;

You may not qualify if:

• Received any investigational drugs within 14 days before the screening test;
• Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study;
• Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
• History of drug or food allergies;
• Abnormal blood pressure or pulse，Abnormal laboratory tests;
• Participated in other clinical trials within 3 months before screening;
• Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;
• Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
• Clinically apparent disease/infection within 1 month before screening;
• The researchers determined that there were other conditions that were not suitable for the trial;

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 311009, China

Location

MeSH Terms

Interventions

vorolanib

Study Officials

• zourong ruan

  the Second Affiliated Hospital of Zhejiang University Medical College

  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

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: December 19, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)