A Food-Effect Study of SHC014748M in Healthy Subjects

NCT04006860 | Unknown Phase 1

• 1 other identifier: SHC014-I-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• tmax

  72 hours

• AUC[%Extrap obs]

  72 hours

• t l/2

  72 hours

• λz

  72 hours

• CL/F

  72 hours

Study Arms (2)

SHC014748M: Fast + Fed

EXPERIMENTAL

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: Fed + Fast

EXPERIMENTAL

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

Interventions

SHC014748M Capsules DRUG

SHC014748M Capsules: 200mg

SHC014748M: Fast + Fed; SHC014748M: Fed + Fast

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male subject,18-45 years of age.
• \. BMI between 19 and 26; Weight between 50 and 80 kg.
• \. Healthy medical examination ,various laboratory inspection indicators normal, or the abnormal signs have no clinical significance.
• \. Subjects (including their partners) who are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last dose.
• \. Sign the informed consent form before the study and fully understand the study content, process and possible adverse reactions.

You may not qualify if:

• \. 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.
• \. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity.
• \. Addicted to smoking and drinking in 3 months before the trial.
• \. Hemorrhage over 200mL , receive blood transfusions or use blood products in 3 months before the trial.
• \. Other conditions not suitable for trial, by judgement of investigator.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233070, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)