Phase 1 Clinical Pharmacology Study of JTZ-951
Phase 1
Completed
- Conditions
- Chronic Kidney Disease
- Registration Number
- JPRN-jRCT2080221924
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
After single oral dose administration of JTZ-951 in CKD patients receiving maintenance hemodialysis, JTZ-951 was absorbed rapidly and the plasma concentration declined in a biphasic manner. Single-dose administration of JTZ-951 was well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Patients undergoing hemodialysis consistently 3 times weekly
-Dry weight between 35kg and 70kg
Exclusion Criteria
-Systolic blood pressure of 180 mmHg or more and diastolic blood pressure of 110 mmHg or more
-Patients with congestive heart failure
-Patients with malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>-Plasma concentrations of JTZ-951<br>-Subjective symptoms, objective findings, vital signs, 12-lead ECG, laboratory tests
- Secondary Outcome Measures
Name Time Method