Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/29/2016 |
| Start Date: | October 2015 |
| End Date: | April 2016 |
A Phase 1, Open-label Study to Evaluate the Effect of Lapatinib, a BCRP Inhibitor, on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease Receiving Hemodialysis
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.
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.
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
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