Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects

Sponsor

InventisBio Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT05226338

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy Female Volunteer	Drug: D-0502	Phase 1

Detailed Description

Phase 1, Open Label, Randomized, Single dose, 3 Period, 3 treatment study to evaluation the relative Bioavailability of D-0502 tablet formulation in healthy female subjects

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-Label, Randomized, Single Dose, 3-Period, 3-Treatment Study to Evaluate the Relative Bioavailability of D-0502 Tablet Formulations in Healthy Female Subjects

Actual Study Start Date :

Oct 27, 2021

Actual Primary Completion Date :

Dec 23, 2021

Actual Study Completion Date :

May 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3
Experimental: Sequence 2 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3
Experimental: Sequence 3 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3
Experimental: Sequence 4 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3
Experimental: Sequence 5 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3
Experimental: Sequence 6 3 period, 3 dose level	Drug: D-0502 Formulation 1 Formulation 2 Formulation 3

Outcome Measures

Primary Outcome Measures

Access the oral bioavailability of D-0502 100mg and 200mg tablets [Single Dose, 3 period, 3 treatment study separated by 14 day washout periods to evaluate safety and bioavailability. Overall time in study is approximately 42 days.]
Access the oral bioavailability of D-0502 100mg and 200mg tablets relative to D-0502 50mg tablet formulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy female subjects between the ages of 18-55
Required evaluation by Investigator for screening and enrollment
Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

Significant medical history or current comorbidly determined by the Investigator.
Pregnant or nursing women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit	Daytona Beach	Florida	United States	32114

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:

NCT05226338

Other Study ID Numbers:

D0502-104

First Posted:

Feb 7, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 8, 2022