Mass Balance Recovery
Conditions
Brief summary
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of \[14C\] D-0502 Following Single Oral Dose Administration
Interventions
DRUG[14C]-D-0502
Drug: \[14C\]-D-0502 and D-0502
Sponsors
InventisBio Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult female volunteers not of child-bearing potential between the ages of 18 and 65. Other inclusion criteria will be reviewed by the Principal Investigator.
Exclusion criteria
* History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives * Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiolabel recovery | 14 days | To assess the mass balance (i.e., cumulative excretion in urine and feces) of D 0502 and the percentages of radiolabel recovered in urine and feces following administration of a single oral dose of D-0502/5 microcuries (µCi) \[14C\] D-0502 in healthy, adult female subjects |
Countries
United States
Outcome results
None listed