Study in Healthy Adult Female Subjects

InventisBio Co., Ltd8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mass Balance Recovery

Interventions

[14C]-D-0502DRUG

Drug: \[14C\]-D-0502 and D-0502

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site Location

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Radiolabel recovery

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

Time frame: 14 days

Data from ClinicalTrials.gov

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