Study in Healthy Adult Female Subjects

Sponsor
InventisBio Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05339633
Collaborator
(none)
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1
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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

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Aug 2, 2022
Anticipated Study Completion Date :
Oct 31, 2022

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

  1. 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

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
InventisBio Co., Ltd
ClinicalTrials.gov Identifier:
NCT05339633
Other Study ID Numbers:
  • D0502-103
First Posted:
Apr 21, 2022
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 23, 2022