NCT05198778

A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

An Open, Single Dose Designed Clinical Study to Evaluate Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of URC102 in Patients With Renal Impairment Under Fasted Conditions and Healthy Adult Volunteers Under Fasted and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.

Detailed description

This trial will evaluate 1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions. 2. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single doses of URC102 in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.

Conditions

• Healthy, Renal Impairment

Interventions

Type	Name	Description
DRUG	URC102	tablet
DRUG	URC102	tablet

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-07-13
• Completion: 2022-07-13
• First posted: 2022-01-20
• Last updated: 2022-12-06

Locations

2 sites across 1 country: South Korea