Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
Phase 1
Completed
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Drug: JTZ-951, 14C-JTZ-951
- Registration Number
- NCT02805244
- Lead Sponsor
- Akros Pharma Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JTZ-951, 14C-JTZ-951 JTZ-951, 14C-JTZ-951 Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951
- Primary Outcome Measures
Name Time Method Radioactivity concentration in urine, feces and dialysate maximum 20 days Radioactivity concentration in whole blood and plasma maximum 20 days Plasma concentrations of JTZ-951 and its metabolite maximum 20 days Cmax (maximum concentration) maximum 20 days tmax (time to reach maximum concentration) maximum 20 days AUC (area under the concentration-time curve) maximum 20 days t1/2 (elimination half-life) maximum 20 days Number of adverse events maximum 20 days
- Secondary Outcome Measures
Name Time Method