| Trial ID: | L5461 |
| Source ID: | NCT06246175
|
| Associated Drug: |
Hrs9531
|
| Title: |
A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531
|
| Outcome Measures: |
Primary: Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Tlast (AUC0-t), Start of Treatment up to Day 29|Maximum Concentration of HRS9531 (Cmax), Start of Treatment up to Day 29|Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf), Start of Treatment up to Day 29 | Secondary: Time to maximum concentration (Tmax), Start of Treatment up to Day 29|Apparent terminal half-life (t1/2), Start of Treatment up to Day 29|Apparent clearance (CL/F), Start of Treatment up to Day 29|Apparent volume of distribution (Vz/F), Start of Treatment up to Day 29|Incidence and severity of adverse events, Screening period up to Day 29
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-28
|
| Completion Date: |
2024-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-03-06
|
| Locations: |
Chengdu Xinhua Hospital, Chengdu, Sichuan, 610000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06246175
|
