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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Anemia of Chronic Kidney Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805244

AZ951-U-15-010

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

JTZ-951, 14C-JTZ-951

Experimental group

Description:

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

Treatment:

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