Back to resultsStudy to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JTZ-951
Lapatinib
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring JTZ-951, Lapatinib, Pharmacokinetics
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: JTZ-951 and Lapatinib
Arm Description
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
Outcomes
Primary Outcome Measures
Cmax (maximum concentration)
tmax (time to reach maximum concentration)
AUC (area under the concentration-time curve)
t1/2 (elimination half-life)
Number of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02581124
Brief Title
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
JTZ-951, Lapatinib, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: JTZ-951 and Lapatinib
Arm Type
Experimental
Arm Description
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
Intervention Type
Drug
Intervention Name(s)
JTZ-951
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Primary Outcome Measure Information:
Title
Cmax (maximum concentration)
Time Frame
10 days
Title
tmax (time to reach maximum concentration)
Time Frame
10 days
Title
AUC (area under the concentration-time curve)
Time Frame
10 days
Title
t1/2 (elimination half-life)
Time Frame
10 days
Title
Number of adverse events
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
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