Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/30/2016 |
| Start Date: | June 2016 |
| End Date: | September 2016 |
A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis
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).
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).
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
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