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

Sponsor

Akros Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02581124

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of Chronic Kidney Disease	Drug: JTZ-951 Drug: Lapatinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: JTZ-951 Drug: Lapatinib

Arm

Intervention/Treatment

Experimental: 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

Drug: JTZ-951

Drug: Lapatinib

Outcome Measures

Primary Outcome Measures

Cmax (maximum concentration) [10 days]
tmax (time to reach maximum concentration) [10 days]
AUC (area under the concentration-time curve) [10 days]
t1/2 (elimination half-life) [10 days]
Number of adverse events [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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