Skip to main content
OpenTrials
Completed

NCT Number: NCT05392127

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.18 ≤ age ≤45, healthy male; 2.Subjects with body weight ≥ 50 kg, and 19≤BMI ≤26 kg/m2 ; 3.Subjects must agree to take effective contraceptive methods from signing informed consent to 6 months after the last administration.

Exclusion criteria

  • Subjects with known history or suspected of being allergic to the study drugs;
  • Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
  • Subjects with eGFR less than 90 mL/min/1.73m2;
  • Subjects with systolic blood pressure less than 90 mmHg or more than 140 mmHg, and/or diastolic blood pressure less than 60 mmHg or more than 90 mmHg;
  • Subjects whoes12-Lead ECG QTcF was more than 450 ms or there were other abnormalities determined by the investigator;
  • Subjects with clinically significant abnormalities in coagulation function;
  • Subjects with infectious disease;
  • Subjects with positive of urine drug screen;
  • Subjects with acute illness occurred within 4 weeks prior to the screening period;
  • Subjects who required antimicrobial therapy within 4 weeks prior to the screening period;
  • Subjects with medical history of systemic inflammatory disease, autoimmune disease, recurrent herpes zoster, disseminated herpes zoster, disseminated herpes simplex;
  • Subjects with a history of tuberculosis (TB) within six months prior to the screening period;
  • Subjects with a history of hypoglycemic episodes or fasting blood glucose less than 2.8 mmol/L during screening;
  • Subjects who took inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 within 28 days before the study;
  • Subjects with contraindications for midazolam, warfarin, omeprazole, and repaglinide.

Treatment and study plan

SHR0302 Tablets

Drug

SHR0302 Tablets once daily

Midazolam Maleate Tablets

Drug

Midazolam Maleate Tablets single dose

Warfarin Sodium Tablets

Drug

Warfarin Sodium Tablets single dose

Omeprazole Enteric Capsules

Drug

Omeprazole Enteric Capsules single dose

Vitamin K1 Tablets

Drug

Vitamin K1 Tablets once daily

Repaglinide Tablets

Drug

Repaglinide Tablets single dose

Primary outcomes

  1. Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  2. AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  3. AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

Secondary outcomes

  1. Tmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  2. t1/2,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  3. CL/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  4. Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302

    Time frame: Days 1-29

  5. Number of subjects with adverse events and severity of adverse events

    Time frame: Up to 35 days

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.