A Food-Effect Study of SHC014748M in Healthy Subjects

NCT ID: NCT04006860

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2019-12-31

Brief Summary

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of SHC014748M Capsules following single dose administration with and without a meal.

Detailed Description

This study will be an open-label, randomized, two-period, crossover PK food effect study of SHC014748M Capsules administered orally at 200 mg.

For each of 2 study periods, subjects will be admitted to the clinical research unit on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 200 mg SHC014748M Capsules in either the fasted or fed state. Subjects will remain at the clinical research unit for at least 72 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHC014748M: Fast + Fed

Participants will receive a single oral dose of SHC014748M capsules in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fed condition on Day 8 of treatment period 2.

Group Type: EXPERIMENTAL

SHC014748M Capsules

Intervention Type: DRUG

SHC014748M Capsules: 200mg

SHC014748M: Fed + Fast

Participants will receive a single oral dose of SHC014748M capsules in fed condition on Day 1 of treatment period 1 followed by a single oral dose of SHC014748M capsules in fasted condition on Day 8 of treatment period 2.

Group Type: EXPERIMENTAL

SHC014748M Capsules

Intervention Type: DRUG

SHC014748M Capsules: 200mg

Interventions

SHC014748M Capsules

SHC014748M Capsules: 200mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Healthy male subject,18-45 years of age.

2. BMI between 19 and 26; Weight between 50 and 80 kg.

3. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.

4. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.

5. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.

Exclusion Criteria

• 1. Nervous system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, musculoskeletal system, etc. are abnormal and have clinical significance as determined by investigator.

2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.

3. Addicted to smoking and drinking in 3 months before the trial.

4. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.

5. Other conditions not suitable for trial, by judgement of investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Sanhome Pharmaceutical, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Countries

China

Facility Contacts

Huan Zhou, associate professor

Role: primary

zhouhuan@bbmc.edu.cn

13665527160

Other Identifiers

SHC014-I-02

Identifier Type: -

Identifier Source: org_study_id