Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
- Registration Number
- NCT02581124
- Lead Sponsor
- Akros Pharma Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: JTZ-951 and Lapatinib JTZ-951 Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5 Experimental: JTZ-951 and Lapatinib Lapatinib Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
- Primary Outcome Measures
Name Time Method AUC (area under the concentration-time curve) 10 days Cmax (maximum concentration) 10 days Number of adverse events 10 days tmax (time to reach maximum concentration) 10 days t1/2 (elimination half-life) 10 days
- Secondary Outcome Measures
Name Time Method