Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- Akros Pharma Inc.
- Study ID
- NCT02581124
- Phase
- PHASE1
- Status
- Completed
Conditions
- Anemia of Chronic Kidney Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- JTZ-951 — DRUG
- Lapatinib — DRUG
Study Details
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.
Key Dates
- Start date
- Oct 31, 2015
- Status verified
- Apr 2016
- Primary completion
- Apr 30, 2016
- Completion
- Apr 30, 2016
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental: JTZ-951 and LapatinibTablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
Primary Outcome Measure
Cmax (maximum concentration) [ Time Frame: 10 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Minneapolis | Minnesota | - | - |