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

Sponsor

Akros Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02805244

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anemia of Chronic Kidney Disease	Drug: JTZ-951, 14C-JTZ-951	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JTZ-951, 14C-JTZ-951 Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951	Drug: JTZ-951, 14C-JTZ-951

Arm

Intervention/Treatment

Experimental: JTZ-951, 14C-JTZ-951

Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951

Drug: JTZ-951, 14C-JTZ-951

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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