Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions

Healthy Volunteer Clinical Trial

Official title:

A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03973632
• Other study ID #: SHC013-I-03
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2019
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Nanjing Sanhome Pharmaceutical, Co., Ltd.
• Contact: Zhou Huan, associate professor
• Phone: 13665527160
• Email: zhouhuan[@]bbmc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.

Description:

By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy Subject with acceptable laboratory results.

2. BMI between 19 and 26; Weight between 50 and 80 kg

3. Not allowed to smoke or drink during the trial.

4. Subject should be willing to contracept during the study and until 6 months after completion of study.

Exclusion Criteria:

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.

2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity

3. Addicted to smoking and drinking.

4. Hemorrhage over 200mL in 3 months before the trial.

5. Other conditions not suitable for trial, by judgement of investigator.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• SH-1028 Tablets
200mg of SH-1028 Tablets, orally once every cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sanhome Pharmaceutical, Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to infinity (AUC)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2(Each cycle is 4 days with a 3-days interval).
Primary	Pharmacokinetic of SH-1028 Tablets by assessment of the area under the plasma concentration-time curve from zero to last measurable concentration [AUC(0-t)]		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Primary	Pharmacokinetic of SH-1028 Tablets by assessment of time to Cmax (tmax)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Every cycle is 4 days with a 3-days interval).
Secondary	Adverse event(AE)rate and serious adverse event(SAE)rate		From signing of informed consent to ending of the trial, about 25 days.
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of maximum plasma concentration (Cmax)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (?z) [		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of Terminal half life (t1/2)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of apparent plasma clearance (CL/F)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of apparent volume of distribution (Vz/F)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of Mean Residence Time(MRT)		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).
Secondary	Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-8) to AUC		Blood samples are collected pre dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose on first day of cycle 1 and 2 (Each cycle is 4 days with a 3-days interval).