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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: SH-1028 Tablets

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhou Huan, associate professor; Phone Number: 13665527160; Email: zhouhuan@bbmc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; 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.	Drug: SH-1028 Tablets; 200mg of SH-1028 Tablets, orally once every cycle.
EXPERIMENTAL: Group B; 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.	Drug: SH-1028 Tablets; 200mg of SH-1028 Tablets, orally once every cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 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 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 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 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 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).
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).

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SHC013-I-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No