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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Female Volunteer
• Intervention / Treatment: Drug: D-0502

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Labcorp Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access the oral bioavailability of D-0502 100mg and 200mg tablets	Access the oral bioavailability of D-0502 100mg and 200mg tablets relative to D-0502 50mg tablet formulation	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.

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2021
• Primary Completion (ACTUAL): December 23, 2021
• Study Completion (ACTUAL): May 11, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D0502-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No