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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805244
• Other study ID #: AZ951-U-15-010
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2016
• Last updated: November 28, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• JTZ-951, 14C-JTZ-951

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radioactivity concentration in urine, feces and dialysate		maximum 20 days	No
Primary	Radioactivity concentration in whole blood and plasma		maximum 20 days	No
Primary	Plasma concentrations of JTZ-951 and its metabolite		maximum 20 days	No
Primary	Cmax (maximum concentration)		maximum 20 days	No
Primary	tmax (time to reach maximum concentration)		maximum 20 days	No
Primary	AUC (area under the concentration-time curve)		maximum 20 days	No
Primary	t1/2 (elimination half-life)		maximum 20 days	No
Primary	Number of adverse events		maximum 20 days	Yes