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

Phase 1

• Conditions: Healthy Volunteer
• Interventions: Drug: SH-1028 Tablets

• Registration Number: NCT03973632
• Lead Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-02
• Last Update Submitted: 2019-06-02
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Study Start: 2019-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	SH-1028 Tablets	Fasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.
Group B	SH-1028 Tablets	Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.

Primary Outcome Measures

Name	Time	Method
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).
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).
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 Outcome Measures

Name	Time	Method
Adverse event（AE）rate and serious adverse event（SAE）rate	From signing of informed consent to ending of the trial, about 25 days.
Pharmacokinetic of SH-1028 Tablets by assessment of terminal rate constant (λz) [	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).
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).
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).
Pharmacokinetic of SH-1028 Tablets by assessment of AUC[%Extrap obs],the rate of AUC(t-∞) 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).
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).
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).
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).