Trials / Completed
CompletedNCT02805244
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Akros Pharma Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JTZ-951, 14C-JTZ-951 |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2016-06-17
- Last updated
- 2016-11-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02805244. Inclusion in this directory is not an endorsement.