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
Overview
- Phase
- Phase 1
- Intervention
- JTZ-951
- Conditions
- Anemia of Chronic Kidney Disease
- Sponsor
- Akros Pharma Inc.
- Enrollment
- 10
- Primary Endpoint
- t1/2 (elimination half-life)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Experimental: JTZ-951 and Lapatinib
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
Intervention: JTZ-951
Experimental: JTZ-951 and Lapatinib
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
Intervention: Lapatinib
Outcomes
Primary Outcomes
t1/2 (elimination half-life)
Time Frame: 10 days
Cmax (maximum concentration)
Time Frame: 10 days
AUC (area under the concentration-time curve)
Time Frame: 10 days
Number of adverse events
Time Frame: 10 days
tmax (time to reach maximum concentration)
Time Frame: 10 days