A Food-Effect Study of SHC014748M in Healthy Subjects

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: SHC014748M Capsules

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233070
      • The First Affiliated Hospital of Bengbu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: SHC014748M Capsules; SHC014748M Capsules: 200mg
EXPERIMENTAL: 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.	Drug: SHC014748M Capsules; SHC014748M Capsules: 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUC(0-∞)	Pharmacokinetic of SHC014748M Capsules by assessment of the area under the plasma concentration-time curve from zero to infinity	72 hours
Cmax	Pharmacokinetic of SHC014748M Capsules by assessment of maximum plasma concentration	72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SHC014-I-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No