FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02581124
Enrollment
10
Registered
2015-10-20
Start date
2015-10-31
Completion date
2016-04-30
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Chronic Kidney Disease

Keywords

JTZ-951, Lapatinib, Pharmacokinetics

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.

Interventions

DRUGJTZ-951
DRUGLapatinib

Sponsors

Akros Pharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
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 events10 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026