A Food-Effect Study of SHC014748M in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Two-period Crossover Food-effect Study of SHC014748M in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04006860
• Other study ID #: SHC014-I-02
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2019
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Nanjing Sanhome Pharmaceutical, Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• SHC014748M Capsules
SHC014748M Capsules: 200mg

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sanhome Pharmaceutical, Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t)	Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.	72 hours
Primary	AUC(0-8)	Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity	72 hours
Primary	Cmax	Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration	72 hours
Secondary	tmax	Pharmacokinetic of SHC014748M Capsules by assessment of time to Cmax	72 hours
Secondary	AUC[%Extrap obs]	Pharmacokinetic of SHC014748M Capsules by assessment of AUC[%Extrap obs],the rate of AUC(t-8) to AUC	72 hours
Secondary	t l/2	Pharmacokinetic of SHC014748M Capsules by assessment of Terminal half life	72 hours
Secondary	?z	Pharmacokinetic of SHC014748M Capsules by assessment of terminal rate constant	72 hours
Secondary	CL/F	Pharmacokinetic of SHC014748M Capsules by assessment of apparent plasma clearance	72 hours
Secondary	Vz/F	Pharmacokinetic of SHC014748M Capsules by assessment of apparent volume of distribution	72 hours
Secondary	MRT	Pharmacokinetic of SHC014748M Capsules by assessment of Mean Residence Time	72 hours