A clinical pharmacology study of TMX-049 in subjects with normal renal function or impaired renal function.

Phase 2

Completed

Conditions: Subjects with normal renal function and patients with impaired renal function.

Registration Number: jRCT2080224863

Lead Sponsor: Teijin Pharma Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: completed

Sex: Male

Target Recruitment: 24

Inclusion Criteria

-Estimated eGFR(mL/min/1.73 m2) * within the categories shown below 1)Severe renal impairment: 10 =< eGFR < 30
2)Moderate renal impairment: 30 =< eGFR < 60 3)Normal renal function: 90 =< eGFR *: calculated using the eGFRcreat Formula -Serum urate => 5.0 mg/dL etc

Exclusion Criteria

-Patients who have gouty arthritis -Patients who have malignant tumor -Patients who have severe hepatic insufficiency -Patients who have poor blood pressure control -Patients who have poor glycaemic control etc

Study & Design

Study Type: Interventional

Study Design: Multicenter, Open-label

Primary Outcome Measures

Name	Time	Method
Plasma TEI-R04969(unchanged drug)		Plasma TEI-R04969(unchanged drug)
Urinary TEI-R04969(unchanged drug)		Urinary TEI-R04969(unchanged drug)
protein binding ratio		protein binding ratio
Serum urate		Serum urate
Adverse events		Adverse events
Clinical laboratory tests		Clinical laboratory tests
Vital signs		Vital signs
Standard 12-lead ECG		Standard 12-lead ECG