Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/3/2014 |
| Start Date: | October 2013 |
| End Date: | March 2014 |
| Contact: | Hisashi Kodama, Ph.D. |
| Email: | kodama@akrospharma.com |
| Phone: | 609-919-6111 |
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
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
(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
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
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