Healthy Female VolunteerPhase 1NCT05226338
Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects
A Phase 1 study testing D-0502 in people with Healthy Female Volunteer, run by InventisBio Co., Ltd at 1 site in United States.
Trial summary
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Volunteer
- What is being tested?
- D-0502
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 11 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Significant medical history or current comorbidly determined by the Investigator.
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit
Daytona Beach, Florida, 32114
About this study
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
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects
Read the 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
- Conditions
- Healthy Female Volunteer
- Being tested
- D-0502
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0502Drug
Formulation 1 Formulation 2 Formulation 3
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
| Sequence 2 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
| Sequence 3 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
| Sequence 4 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
| Sequence 5 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
| Sequence 6 | Experimental | 3 period, 3 dose level Receives: Drug: D-0502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start27 Oct 2021
- Primary completion23 Dec 2021
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female VolunteerStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226338
- Sponsor's protocol ID
- D0502-104
- Status last verified
- Aug 2022
- First submitted
- 22 Oct 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05226338
- Acronym / sponsor ID
- D0502-104
- Conditions
- Healthy Female Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relative Bioavailability study of D-0502 tablet formulation in healthy female subjects
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: D-05023 period, 3 dose level |
| Sequence 2 | Experimental | Drug: D-05023 period, 3 dose level |
| Sequence 3 | Experimental | Drug: D-05023 period, 3 dose level |
| Sequence 4 | Experimental | Drug: D-05023 period, 3 dose level |
| Sequence 5 | Experimental | Drug: D-05023 period, 3 dose level |
| Sequence 6 | Experimental | Drug: D-05023 period, 3 dose level |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Significant medical history or current comorbidly determined by the Investigator.
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-0502Formulation 1 Formulation 2 Formulation 3 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Access the oral bioavailability of D-0502 100mg and 200mg tablets
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-0502 in people with Healthy Female Volunteer, run by InventisBio Co., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access the oral bioavailability of D-0502 100mg and 200mg tablets (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.