Breast CancerPhase 1NCT03810625
Food Effect Study of D-0502 Tablet in Healthy Volunteers
A Phase 1 study testing D-0502 in people with Breast Cancer, run by InventisBio Co., Ltd at 1 site in United States.
Trial summary
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- D-0502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 17 Apr 2019
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be medically documented as healthy and acceptable at physical examination.
- Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher.
- Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- Subjects must be female with postmenopausal status defined as meeting at least one of the following criteria:
- Have undergone a bilateral oophorectomy any time in life;
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- Age ≥60 years, or
- Age <60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]).
- Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Who cannot join
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator.
- Subjects who have any history or suspicion of kidney stones.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.
- Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before Day 1 of study medication dosing.
- Subjects had undergone major surgery within 3 months prior to Day 1.
- Subjects who is participating in a clinical research study involving the administration of an investigational or marketed drug or device, or who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
- Subjects with positive urine drug screen test at screening.
- Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase I, Randomized, Open Label, Two-Sequence, Two-Period Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of D-0502 Tablet in Postmenopausal Female Healthy Subjects
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.
- Conditions
- Breast Cancer
- Being tested
- D-0502
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0502Drug
D-0502 oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state. Receives: Drug: D-0502 |
| Sequence BA | Experimental | D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state. Receives: Drug: D-0502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM*hr
Measured: Day 1 through 4, Day 7 through 11
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0502; Unit: nM
Measured: Day 1 through 4, Day 7 through 11
Pharmacokinetic: Time to reach the Cmax (Tmax)
Tmax: Time to reach the Cmax of D-0502; Unit: hr
Measured: Day 1 through 4, Day 7 through 11
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0502; Unit: hr
Measured: Day 1 through 4, Day 7 through 11
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Number of treatment-related adverse events as assessed by CTCAE v4.0
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start23 Oct 2018
- Primary completion21 Nov 2018
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 14 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
- NCT03810625
- Sponsor's protocol ID
- IBIO-302
- Status last verified
- Aug 2019
- First submitted
- 16 Dec 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open Label, Two-Sequence, Two-Period Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of D-0502 Tablet in Postmenopausal Female Healthy Subjects
- ClinicalTrials.gov ID
- NCT03810625
- Acronym / sponsor ID
- IBIO-302
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 18 Jan 2019 (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.
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: D-0502D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state. |
| Sequence BA | Experimental | Drug: D-0502D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be medically documented as healthy and acceptable at physical examination.
- Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher.
- Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- Subjects must be female with postmenopausal status defined as meeting at least one of the following criteria:
Key exclusion criteria (8 listed)
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator.
- Subjects who have any history or suspicion of kidney stones.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.
- Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before Day 1 of study medication dosing.
- Subjects had undergone major surgery within 3 months prior to Day 1.
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-0502D-0502 oral tablets | Drug | Sequence AB, Sequence BA |
Primary outcome
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 through 4, Day 7 through 11
AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM*hr
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Time frame: Day 1 through 4, Day 7 through 11
Cmax: maximum plasma drug concentration of D-0502; Unit: nM
Pharmacokinetic: Time to reach the Cmax (Tmax)
Time frame: Day 1 through 4, Day 7 through 11
Tmax: Time to reach the Cmax of D-0502; Unit: hr
Pharmacokinetic: Apparent terminal half-life (t1/2)
Time frame: Day 1 through 4, Day 7 through 11
t1/2: apparent terminal half-life of D-0502; Unit: hr
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 weeks
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 7 Aug 2019.
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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 Breast Cancer, 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 9 inclusion and 8 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 7 Aug 2019. 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?
Pharmacokinetic: area under the plasma concentration versus time curve (AUC) (time frame: Day 1 through 4, Day 7 through 11). The study lists 4 primary outcomes in all. 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 7 Aug 2019.