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Completed

NCT Number: NCT05273775

A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
  • Healthy subjects aged 18~50 (including 18 and 50 years old);
  • Body weight ≥ 50 kg, body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height2 (m2));
  • Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception.

Exclusion criteria

  • Has the medicine or food allergy history, or is the allergic constitution person;
  • Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption;
  • QTCF > 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance;
  • Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;
  • Those who smoked more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial period;
  • Regular drinkers who had consumed more than 14 units of alcohol per week (1 unit = 285 ml of beer, 25 ml of spirits, or 100 ml of wine) during the six months prior to screening and could not stop using any alcoholic product during the trial; positive Breath test for alcohol;
  • Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration;
  • Anyone who has undergone any surgery within 6 months prior to screening;
  • Clinical trial participants who have participated in any drug or medical device within 3 months prior to screening (subject to the intervention of the experimental drug or medical device);10.Blood donation (or blood loss) within 3 months before screening and the amount of blood donation (or blood loss)≥400 ml, or receiving blood transfusion.

Treatment and study plan

HRS5091 Tablets

Drug

HRS5091 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

Digoxin Tablets

Drug

Digoxin Tablets single dose

Rosuvastatin Calcium Tablets

Drug

Rosuvastatin Calcium Tablets single dose

Primary outcomes

  1. Cmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

  2. AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

  3. AUC0-∞,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

Secondary outcomes

  1. Tmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

  2. t1/2,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

  3. CL/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

  4. Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

    Time frame: Days 1-27

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

    Time frame: Up to 56 days

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Study of the Effects of HRS5091 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin and Rosuvastatin in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Dec 23, 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.

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