Site Location
Baltimore, Maryland, 21201, United States
Completed
NCT Number: NCT05339633
Study in Healthy Adult Female Subjects
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
Completed
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Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
[14C]-D-0502
DrugDrug: [14C]-D-0502 and D-0502
Primary outcomes
-
Radiolabel recovery
Time frame: 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
Sponsors and collaborators
Lead sponsor
InventisBio Co., Ltd
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Apr 21, 2022
- Registry last updated
- Apr 6, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.