| Trial ID: | L0612 |
| Source ID: | NCT01978587
|
| Associated Drug: |
Jtz-951
|
| Title: |
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia in Chronic Kidney Disease
|
| Interventions: |
DRUG: JTZ-951
|
| Outcome Measures: |
Primary: 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: Number of subjects with adverse events, 14 days|Vital signs and ECG (electrocardiogram), 14 days
|
| Sponsor/Collaborators: |
Sponsor: Akros Pharma Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2014-01
|
| Results First Posted: |
|
| Last Update Posted: |
2014-03-18
|
| Locations: |
Minneapolis, Minnesota, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01978587
|
