Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2013
Shorter than P25 for phase_1
1 active site
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, 2013
CompletedFirst Submitted
Initial submission to the registry
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 18, 2014
March 1, 2014
2 months
November 1, 2013
March 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Days 1 to 4 and 8 to 11
Secondary Outcomes (2)
Number of subjects with adverse events
14 days
Vital signs and ECG (electrocardiogram)
14 days
Study Arms (2)
Dose 1 JTZ-951
EXPERIMENTALTablets, 1 dose on Day 1 before hemodialysis
Dose 2 JTZ-951
EXPERIMENTALTablets, 1 dose on Day 8 after hemodialysis
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
You may not qualify if:
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
- Uncontrolled hypertension at the Screening Visit or Day -1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Minneapolis, Minnesota, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hideyuki Yamamoto
Akros Pharma Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 7, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
March 18, 2014
Record last verified: 2014-03