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

Completed · Phase 1

Conditions studied: Anemia of Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT02805244

Run by

Akros Pharma Inc.

People needed

6

Starts

2016-06-01

Expected to finish

2016-09-01

Last updated by the study team

2016-11-29

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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