NCT02581124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

October 19, 2015

Last Update Submit

April 27, 2016

Conditions

Anemia of Chronic Kidney Disease

Keywords

JTZ-951LapatinibPharmacokinetics

Outcome Measures

Primary Outcomes (5)

  • 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 events

    10 days

Study Arms (1)

Experimental: JTZ-951 and Lapatinib

EXPERIMENTAL

Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5

Drug: JTZ-951Drug: Lapatinib

Interventions

JTZ-951DRUG
Experimental: JTZ-951 and Lapatinib
LapatinibDRUG
Experimental: JTZ-951 and Lapatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, United States

Location

MeSH Terms

Interventions

enarodustatLapatinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(1)