Trials Sponsors Conditions Drugs Pricing

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

The maximum plasma concentration (Cmax)
Post-dose at Day 1 to Day 44.
Area under the blood drug concentration-time curve from time 0 corresponding to the last quantifiable concentration time (AUC0-t)
Post-dose at Day 1 to Day 44.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-∞)
Post-dose at Day 1 to Day 44.

Secondary Outcomes (7)

Time to maximum plasma concentration (Tmax)
Post-dose at Day 1 to Day 44.
Terminal half-life (t1/2)
Post-dose at Day 1 to Day 44.
Terminal elimination rate constant (λz)
Post-dose at Day 1 to Day 44.
Volume of distribution at steady state (Vss)
Post-dose at Day 1 to Day 44.
Total systemic clearance / Total body clearance (CL)
Post-dose at Day 1 to Day 44.
+2 more secondary outcomes

Study Arms (1)

HRS4642 + Itraconazole capsules Group

EXPERIMENTAL

Healthy subjects received HRS4642 and itraconazole capsules.

Drug: HRS4642Drug: Itraconazole Capsules

Interventions

HRS4642Drug

HRS4642.

HRS4642 + Itraconazole capsules Group

Itraconazole CapsulesDrug

Itraconazole capsules.

HRS4642 + Itraconazole capsules Group

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Itraconazole Capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Itraconazole Capsules
Named ingredient: Itraconazole
View registry record

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
Male participants with body weight ≥ 50.0 kg, female participants with body weight ≥ 45.0 kg, and body mass index (BMI) between 19 and 26 kg/m² (inclusive of both endpoints).

Sponsors & Collaborators

Shanghai Hengrui Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Xiangya Third Hospital of Central South University

Changsha, Hunan, 410013, China

Guoping YangCONTACT+86-0731-89918665 ygp9880@163.com

Guoping YangPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Fen Yao

CONTACT

+86-0518-82342973 fen.yao.fy3@hengrui.com

Jing He

CONTACT

+86-0518-82342973

Study Design

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

Study Record Dates

First Submitted

October 25, 2026

First Posted

October 30, 2026

Study Start

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

You may not qualify if:

A history of or current presence of any clinically significant disease of the circulatory, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, or psychiatric systems, or metabolic disorders, or any other condition that may interfere with the study results.
Poorly controlled or severe cardiovascular/cerebrovascular disease or arterial/venous thrombotic events within 6 months prior to study entry, such as cerebral hemorrhage, cerebral infarction, severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA Class II-IV), myocardial infarction, arrhythmia requiring clinical intervention, deep vein thrombosis, etc.
Carotid ultrasound showing stenosis ≥ 50% (the ECST method is preferred) or presence of more than 2 high-risk plaques.
Surgery within 6 months prior to screening, or planned surgery during the study period.
Previous surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, gastric bypass/bariatric surgery, etc.), or need for gastric acid-neutralizing medications (e.g., aluminum hydroxide) during the study.
Blood donation or significant blood loss (≥ 400 mL), blood transfusion, or use of blood products within 3 months prior to screening.
Regular use of sedatives, hypnotics, or other addictive drugs; a history of drug abuse within 1 year prior to screening, or a positive urine drug abuse screen.
Participation in any clinical trial with administration of investigational drugs within 3 months prior to the first dose.
Smoking more than 5 cigarettes per day within 3 months prior to screening, and inability to stop using any tobacco products during the study period.
Regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine), and inability to stop using any alcohol-containing products during the study period; positive breath alcohol test.
Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram (ECG), abdominal ultrasound, chest X-ray, complete blood count, blood biochemistry, urinalysis, or coagulation tests during the screening period.
Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (anti-HCV), positive syphilis antibody, or positive HIV antibody.
History of needle phobia or blood-injection phobia, difficulty with blood collection, or inability to tolerate venipuncture blood sampling.
Pregnant or lactating women.
Participants with other factors deemed by the investigator to be unsuitable for participation in this study.

A Study to Assess the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Following Intravenous Infusion in Healthy Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (1)

HRS4642 + Itraconazole capsules Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (1)

HRS4642 + Itraconazole capsules Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations