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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805244

Enrollment

Registered

2016-06-17

Start date

2016-06-30

Completion date

2016-09-30

Last updated

2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Chronic Kidney Disease

Keywords

JTZ-951, Pharmacokinetics, 14C-JTZ-951, Mass balance, Time course

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).

Interventions

DRUGJTZ-951, 14C-JTZ-951

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
t1/2 (elimination half-life)	maximum 20 days
Number of adverse events	maximum 20 days
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026