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

Completed · Phase 1

Conditions studied: Anemia of Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02581124

Run by

Akros Pharma Inc.

People needed

10

Starts

2015-10-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.