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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581124
• Other study ID #: AZ951-U-15-009
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2015
• Last updated: April 27, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• JTZ-951

• Lapatinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum concentration)		10 days	No
Primary	tmax (time to reach maximum concentration)		10 days	No
Primary	AUC (area under the concentration-time curve)		10 days	No
Primary	t1/2 (elimination half-life)		10 days	No
Primary	Number of adverse events		10 days	Yes