Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
- Registration Number
- NCT01978587
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
Exclusion Criteria
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
- Uncontrolled hypertension at the Screening Visit or Day -1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dose 1 JTZ-951 JTZ-951 Tablets, 1 dose on Day 1 before hemodialysis Dose 2 JTZ-951 JTZ-951 Tablets, 1 dose on Day 8 after hemodialysis
- Primary Outcome Measures
Name Time Method Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis Days 1 to 4 and 8 to 11 AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis Days 1 to 4 and 8 to 11 tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis Days 1 to 4 and 8 to 11 t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis Days 1 to 4 and 8 to 11
- Secondary Outcome Measures
Name Time Method Vital signs and ECG (electrocardiogram) 14 days Number of subjects with adverse events 14 days