Relative Bioavailability Study of SHR3680

NCT04903158 | Unknown Phase 1

• 1 other identifier: SHR3680-BA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (4)

• Fr

  Fr=AUC (test formulation)/AUC (reference formulation)

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• Cmax

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• AUC0-t

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• AUC0-∞

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

Secondary Outcomes (5)

• Tmax

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• T1/2

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• Vd

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• CL/F

  predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing

• The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)

  From the screening to the scheduled last visit day (Day 49±1 after dosing)

Study Arms (2)

Test group

EXPERIMENTAL

Test formulation of SHR3680

Drug: test SHR3680 tablets

Reference group

OTHER

Reference formulation of SHR3680.

Drug: reference SHR3680 tablets

Interventions

test SHR3680 tablets DRUG

Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg\*3)

Test group

reference SHR3680 tablets DRUG

subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg\*2+20mg\*2).

Reference group

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent, and less than 10-year between minimum age and maximum age of the whole subjects;
• Body weight ≥ 50 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
• Agreement to avoid sperm donation for 3 months days after the dose of SHR3680;
• Glomerular filtration rate (GFR) ≥ 90mL / min / 1.73m2 (see Appendix 1 of the clinical trial protocol for the calculation formula of GFR);

You may not qualify if:

• Any history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attacks or any conditions that may lead to seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc;
• Any subject who had any clinically significant acute diseases within one month before screening, including fever or fever as his clinical symptoms, virus, bacteria (including upper respiratory tract infection) or fungi (non-skin) infections;
• Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor);
• Allergic constitution;
• History of drug use, or drug abuse screening positive;
• Alcoholic or often drinkers;
• A smoker with 5 cigarettes per day for more than 90 days;
• Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects);
• Use of any drugs or substances known to be inhibitors or inducers of CYP enzymes within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR3680 administration and during the study.
• A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
• Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
• From 48 hours before taking the study drug to the end of the study, any subject refused to stop using any drinks containing methylxanthine (such as coffee, tea, cola, chocolate, etc.), alcoholic drinks and any fruit juice; they took drinks or foods containing grapefruit 7 days before the first administration of the study drug;
• Those who received vaccination within 3 months before screening.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 26, 2021
• Study Start: January 6, 2021
• Primary Completion: March 15, 2021
• Study Completion: May 1, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

CN (1)