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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia of Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

JTZ-951

Intervention Type DRUG

Lapatinib

Intervention Type DRUG

Interventions

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JTZ-951

Intervention Type DRUG

Lapatinib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No