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

NCT03973632 | Unknown Phase 1

• 1 other identifier: SHC013-I-03
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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).

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

SH-1028 Tablets DRUG

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

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Healthy Subject with acceptable laboratory results.
• BMI between 19 and 26; Weight between 50 and 80 kg
• Not allowed to smoke or drink during the trial.
• Subject should be willing to contracept during the study and until 6 months after completion of study.

You may not qualify if:

• Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
• History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity
• Addicted to smoking and drinking.
• Hemorrhage over 200mL in 3 months before the trial.
• Other conditions not suitable for trial, by judgement of investigator.

Sponsors & Collaborators

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

MeSH Terms

Interventions

SH-1028

Central Study Contacts

Zhou Huan, associate professor

CONTACT

13665527160; zhouhuan@bbmc.edu.cn

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: May 31, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share