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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akros Pharma Inc.
• Treatments: Lapatinib

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 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