| Trial ID: | L0304 |
| Source ID: | NCT02571192
|
| Associated Drug: |
SHP??626.00
|
| Title: |
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis
|
| Interventions: |
Drug: SHP626|Radiation: 5.95 ??Ci RAD
|
| Outcome Measures: |
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.|Total radioactivity (RAD) in whole blood and plasma|To determine the total RAD in urine and feces.|Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)|Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration|Area under the plasma concentration curve (AUC0-??? ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration|First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t??) for 50mg [14C]-SHP626 and RAD|Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed|Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed|Cumulative amount (Aef )of RAD recovered in stool over the dosing interval|Excreted Percent of RAD recovered in stool over the dosing interval|Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval|Excreted Percent of RAD recovered in urine over the dosing interval|Renal Clearance (CLR ) of 50mg [14C]-SHP626|Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification|Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification|Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting|Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings|Changes from baseline in vital signs|Changes from baseline in ECGs|Changes from baseline in hematology|Changes from baseline in coagulation|Changes in baseline in urinalysis|Changes in baseline in chemistry
|
| Sponsor/Collaborators: |
Mirum Pharmaceuticals, Inc.
|
| Gender: |
Male
|
| Age: |
18 Years to 50 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
8
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
October 1, 2015
|
| Completion Date: |
October 1, 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
May 1, 2019
|
| Locations: |
Covance Madison Clinical Research Unit, Madison, Wisconsin, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02571192
|
