Study in Healthy Adult Female Subjects

InventisBio

Status and phase: Completed; Phase 1

Conditions: Mass Balance Recovery

Treatments: Drug: [14C]-D-0502

Study type: Interventional

Funder types: Industry

Identifiers

NCT05339633

D0502-103

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Single Dose

Other group

Description:

All study subjects will receive a a single oral dose of radiolabeled microtracer of D-0502 following an overnight fast

Treatment:

Drug: [14C]-D-0502