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CompletedNCT02581124Updated Apr 28, 2016

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

A Phase 1 interventional study of JTZ-951 and Lapatinib in Anemia of Chronic Kidney Disease, sponsored by Akros Pharma Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-28.

Sponsored by Akros Pharma Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anemia of Chronic Kidney Disease

Keywords

  • JTZ-951
  • Lapatinib
  • Pharmacokinetics
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Akros Pharma Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • DrugJTZ-951
  • DrugLapatinib
06

What researchers measure

Primary outcomes

  1. Cmax (maximum concentration)

    Time frame: 10 days

  2. tmax (time to reach maximum concentration)

    Time frame: 10 days

  3. AUC (area under the concentration-time curve)

    Time frame: 10 days

  4. t1/2 (elimination half-life)

    Time frame: 10 days

  5. Number of adverse events

    Time frame: 10 days

07

Study locations

1 site
  • Minneapolis, Minnesota, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02581124
Lead sponsor
Akros Pharma Inc.
Responsible party
Sponsor
First posted
Oct 20, 2015
Start date
Oct 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 28, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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