Study in Healthy Adult Female Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2022-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Mass Balance Recovery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single Dose

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

Group Type OTHER

[14C]-D-0502

Intervention Type DRUG

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

Interventions

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[14C]-D-0502

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes