A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Overview
- Phase
- Phase 1
- Intervention
- JTZ-951
- Conditions
- Anemia in Chronic Kidney Disease
- Sponsor
- Akros Pharma Inc.
- Enrollment
- 6
- Primary Endpoint
- Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Dose 1 JTZ-951
Tablets, 1 dose on Day 1 before hemodialysis
Intervention: JTZ-951
Dose 2 JTZ-951
Tablets, 1 dose on Day 8 after hemodialysis
Intervention: JTZ-951
Outcomes
Primary Outcomes
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time Frame: Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
Time Frame: Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time Frame: Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Time Frame: Days 1 to 4 and 8 to 11
Secondary Outcomes
- Vital signs and ECG (electrocardiogram)(14 days)
- Number of subjects with adverse events(14 days)