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

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).

Study Overview

• Status: Completed
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: JTZ-951, 14C-JTZ-951

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Mass balance; Time course; JTZ-951; 14C-JTZ-951
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: AZ951-U-15-010