| Trial ID: | L0649 |
| Source ID: | NCT02805244
|
| Associated Drug: |
Jtz-951, 14c-Jtz-951
|
| Title: |
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: JTZ-951, 14C-JTZ-951
|
| Outcome Measures: |
Primary: Radioactivity concentration in urine, feces and dialysate, maximum 20 days|Radioactivity concentration in whole blood and plasma, maximum 20 days|Plasma concentrations of JTZ-951 and its metabolite, maximum 20 days|Cmax (maximum concentration), maximum 20 days|tmax (time to reach maximum concentration), maximum 20 days|AUC (area under the concentration-time curve), maximum 20 days|t1/2 (elimination half-life), maximum 20 days|Number of adverse events, maximum 20 days |
|
| Sponsor/Collaborators: |
Sponsor: Akros Pharma Inc.
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2016-06
|
| Completion Date: |
2016-09
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-29
|
| Locations: |
Minneapolis, Minnesota, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02805244
|
