Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Lapatinib; Drug: JTZ-951

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581124

AZ951-U-15-009

Details and patient eligibility

About

Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.

Enrollment: 10 patients

Sex: All

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 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: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental: JTZ-951 and Lapatinib

Experimental group

Description:

Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5

Treatment:

Drug: JTZ-951

Drug: Lapatinib