Study in Healthy Adult Female Subjects
- Registration Number
- NCT05339633
- Lead Sponsor
- InventisBio Co., Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8
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 exclusion criteria will be reviewed by the Principal Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Dose [14C]-D-0502 All study subjects will receive a a single oral dose of radiolabeled microtracer of D-0502 following an overnight fast
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site Location
🇺🇸Baltimore, Maryland, United States