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

A multi-center, open-label clinical pharmacology study to evaluate the pharmacokinetics, pharmacodynamics and safety of TMX-049 multiple oral administration in subjects with normal renal function or impaired renal function.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224863

Enrollment

Registered

2019-09-11

Start date

2019-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

investigational material(s) Generic name etc : TMX-049 INN of investigational material : - Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Estimated eGFR(mL/min/1.73 m2) * within the categories shown below 1)Severe renal impairment: 10 = 5.0 mg/dL etc

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics pharmacodynamics -Pharmacokinetics Plasma TEI-R04969(unchanged drug), Urinary TEI-R04969(unchanged drug), protein binding ratio -Pharmacodynamics Serum urate -Safety Adverse events, Clinical laboratory tests, Vital signs,Standard 12-lead ECG	—

Secondary

Measure	Time frame
other -	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026