A Food-Effect Study of SHC014748M in Healthy Subjects

Sanhome Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: SHC014748M Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04006860

SHC014-I-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

SHC014748M: Fast + Fed

Experimental group

Description:

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.

Treatment:

Drug: SHC014748M Capsules

SHC014748M: Fed + Fast

Experimental group

Description:

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.

Treatment:

Drug: SHC014748M Capsules