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

Primary Purpose

Anemia of Chronic Kidney Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

JTZ-951, 14C-JTZ-951

About this trial

This is an interventional basic science trial for Anemia of Chronic Kidney Disease focused on measuring JTZ-951, Pharmacokinetics, 14C-JTZ-951, Mass balance, Time course

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JTZ-951, 14C-JTZ-951

Arm Description

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

Outcomes

Primary Outcome Measures

Radioactivity concentration in urine, feces and dialysate

Radioactivity concentration in whole blood and plasma

Plasma concentrations of JTZ-951 and its metabolite

Cmax (maximum concentration)

tmax (time to reach maximum concentration)

AUC (area under the concentration-time curve)

t1/2 (elimination half-life)

Number of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02805244

First Posted

June 15, 2016

Last Updated

November 28, 2016

Sponsor

Akros Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02805244

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akros Pharma Inc.

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia of Chronic Kidney Disease

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JTZ-951, 14C-JTZ-951

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

JTZ-951, 14C-JTZ-951

Primary Outcome Measure Information:

Title

Radioactivity concentration in urine, feces and dialysate

Time Frame

maximum 20 days

Title

Radioactivity concentration in whole blood and plasma

Time Frame

maximum 20 days

Title

Plasma concentrations of JTZ-951 and its metabolite

Time Frame

maximum 20 days

Title

Cmax (maximum concentration)

Time Frame

maximum 20 days

Title

tmax (time to reach maximum concentration)

Time Frame

maximum 20 days

Title

AUC (area under the concentration-time curve)

Time Frame

maximum 20 days

Title

t1/2 (elimination half-life)

Time Frame

maximum 20 days

Title

Number of adverse events

Time Frame

maximum 20 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Minneapolis

State/Province

Minnesota

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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