Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).

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

Details

• Lead Sponsor: Akros Pharma Inc.

Criteria

Inclusion Criteria:

• Subjects with end stage renal disease on hemodialysis

• Post-dialysis body weight >45.0 kg

• BMI between 18.0 and 40.0 kg/m2 (inclusive)

Exclusion Criteria:

• Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0 × upper limit of normal (ULN), or total bilirubin >1.5 × ULN at the Screening Visit

• Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis)

• Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody

• Subjects with known history of liver failure or liver surgery

• Subjects with a history or current clinically significant chronic or acute blood loss