Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects

NCT05404724 | Completed Phase 1

• 1 other identifier: SHR0302-110
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy subjects. To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and combination use in healthy subjects.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• SHR0302 and its main metabolite AUC0-t

  day 1 to day 11

• SHR0302 and its main metabolite AUC0-inf

  day 1 to day 11

• SHR0302 and its main metabolite Cmax

  day 1 to day 11

Secondary Outcomes (5)

• SHR0302 and its main metabolite Tmax (SHR0302 only)

  day 1 to day 11

• SHR0302 and its main metabolite t1/2 (SHR0302 only)

  day 1 to day 11

• SHR0302 and its main metabolite CL/F (SHR0302 only)

  day 1 to day 11

• SHR0302 and its main metabolite Vz/F (SHR0302 only)

  day 1 to day 11

• Adverse events

  Day 1 to Day 17

Study Arms (1)

Treatment group

EXPERIMENTAL

itraconazole and SHR0302 tablets

Drug: itraconazole、 SHR0302 tablets

Interventions

itraconazole、 SHR0302 tablets DRUG

Itraconazole 7 times and SHR0302 tablets twice. On the 8th day of this, itraconazole and SHR0302 tablets were taken simultaneously.

Treatment group

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to strictly comply with the clinical trial protocol to complete this trial;
• Age 18 to 45 years (inclusive, subject to the signing of informed consent), healthy male;
• Body mass ≥ 50 kg and body mass index (BMI): 19 to 26 kg/m2 (both ends included);
• Be able to communicate well with the investigators and understand and comply with the requirements of this study.

You may not qualify if:

• Those who have participated in clinical trials of any drug and medical device within three months before the first administration or who are still in the follow-up period of a clinical study or 5 half-life periods of the test drug before screening (whichever is longer), the participant in the clinical trial is defined as: those who have signed informed consent for clinical trials and have used the test drugs (including placebo) or experimental medical devices;
• Those who have chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years and the researchers believe that there is still clinical significance;
• Those who have a history of respiratory system, cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities, etc., and the researcher believes that there is still clinical significance;
• Patients with a history of ventricular dysfunction;
• Have any history of systemic inflammatory diseases, autoimmune diseases, recurrent herpes zoster, disseminated herpes zoster, and disseminated herpes simplex;
• Those who have a history of tuberculosis (TB) within half a year before the first administration;
• Infections or other acute diseases that need to be treated with antimicrobials (viral, bacterial, fungal, parasitic infections) within 4 weeks before the first administration of the drug are judged by the researchers to be unsuitable for participating in the trial;
• Allergic to the study drug (SHR0302 tablets and itraconazole capsules) or any ingredient in the study drug, or have a history of allergy to drugs, food or other substances;
• Those who cannot tolerate intravenous puncture or have a history of blood sickness and needle sickness;
• Those who have undergone surgery that the researchers judge will affect the absorption, distribution, metabolism and excretion of the drug within 6 months before the first administration; or have undergone surgery within 4 weeks before the first administration; or those who plan to perform surgical operations during the trial period;
• Those who have used any drugs (including Chinese herbal medicines, health care products, etc.) within 14 days before the first administration, or those who plan to take drugs or health care products that are not experimental in this study during the trial period;
• Any drug or food that has been used within 30 days prior to the first administration is an inhibitor or inducer of the cytochrome P4503A4 enzyme (CYP3A4), as detailed in Annex 2;
• those who have received BCG vaccine within 12 months prior to the first dose, or who have been vaccinated or exposed to other live vaccines or live attenuated vaccines within 3 months prior to the first dose, or who plan to be vaccinated during the trial;
• those who donate blood or lose a large amount of blood (\> 400 mL) within 3 months before the first administration, those who receive blood transfusions or use blood products, or those who intend to donate blood or blood components during the trial period or within 3 months after the end of the test;
• Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the first administration of drugs;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Model Details: itraconazole and SHR0302 tablets are used in combination

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: June 25, 2022
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CN (1)