A Food-Effect Study of SHC014748M in Healthy Subjects

Phase 1

• Conditions: Healthy Volunteer
• Interventions: Drug: SHC014748M Capsules

• Registration Number: NCT04006860
• Lead Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHC014748M: Fed + Fast	SHC014748M Capsules	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.
SHC014748M: Fast + Fed	SHC014748M Capsules	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.

Primary Outcome Measures

Name	Time	Method
Cmax	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration
AUC(0-∞)	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity
AUC(0-t)	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration.

Secondary Outcome Measures

Name	Time	Method
t l/2	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of Terminal half life
CL/F	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of apparent plasma clearance
tmax	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of time to Cmax
AUC[%Extrap obs]	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of AUC\[%Extrap obs\],the rate of AUC(t-∞) to AUC
λz	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of terminal rate constant
Vz/F	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of apparent volume of distribution
MRT	72 hours	Pharmacokinetic of SHC014748M Capsules by assessment of Mean Residence Time

Trial Locations

Locations (1)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China