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
1 other identifier
interventional
18
1 country
1
Brief Summary
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2022
CompletedAugust 8, 2022
August 1, 2022
2 months
October 22, 2021
August 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (6)
Sequence 1
EXPERIMENTAL3 period, 3 dose level
Sequence 2
EXPERIMENTAL3 period, 3 dose level
Sequence 3
EXPERIMENTAL3 period, 3 dose level
Sequence 4
EXPERIMENTAL3 period, 3 dose level
Sequence 5
EXPERIMENTAL3 period, 3 dose level
Sequence 6
EXPERIMENTAL3 period, 3 dose level
Interventions
Formulation 1 Formulation 2 Formulation 3
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant medical history or current comorbidly determined by the Investigator.
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Labcorp Clinical Research Unit
Daytona Beach, Florida, 32114, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2021
First Posted
February 7, 2022
Study Start
October 27, 2021
Primary Completion
December 23, 2021
Study Completion
May 11, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share