Status unknownNCT04006860Updated Jul 5, 2019

A Food-Effect Study of SHC014748M in Healthy Subjects

A Phase 1 interventional study of SHC014748M Capsules in Healthy Volunteer, sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd.. Status unknown at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study 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.

Read the 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.

Conditions studied

Healthy Volunteer

In context

Lead sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd. is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 16 participants (estimated)

Study arms

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
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

Interventions

DrugSHC014748M Capsules
SHC014748M Capsules: 200mg

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui 233070, China
- Huan Zhou, associate professor · Contact · zhouhuan@bbmc.edu.cn · 13665527160
- Huaiquan Gao, associate · Principal investigator
- Huan Zhou, associate · Principal investigator

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04006860
Lead sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.
Responsible party: Sponsor
First posted: Jul 5, 2019
Start date: Jul 2019 (estimated)
Primary completion: Dec 2019 (estimated)
Completion: Dec 2019 (estimated)
Last update: Jul 5, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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