Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akros Pharma Inc.

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