Study in Healthy Adult Female Subjects
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Single Dose All study subjects will receive a a single oral dose of radiolabeled microtracer of D-0502 following an overnight fast |
Drug: [14C]-D-0502
Drug: [14C]-D-0502 and D-0502
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Site Location | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- InventisBio Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D0502-103