HealthyPhase 1EPI01NCT03828084
Randomized, Single-dose, Crossover Study of 4 Decitabine and Tetrahydrouridine (EPI01) Formulations in Healthy Subjects
A Phase 1 study testing Decitabine in people with Healthy, run by EpiDestiny, Inc. at 1 site in United States.
Trial summary
To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3 modified release formulations in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Decitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to 3 May 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must understand and voluntarily sign a written ICF prior to any study related procedures being performed and be able to adhere to restrictions and examination schedules.
- Must be able to communicate with the investigator, and to understand and comply with the requirements of the study.
- Healthy male volunteers from any race between 18 to 50 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.
- Must have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 and 100 kg (132 to 220 lb), inclusive, at screening.
- Subject's clinical laboratory test results have no clinically significant findings, in the opinion of the Investigator.
- Vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the subject has rested for at least 5 minutes. At screening, the potential subject must be afebrile, with a systolic blood pressure between 90 and 140 mmHg (inclusive), diastolic blood pressure between 60 and 90 mmHg (inclusive), and pulse rate between 50 and 100 bpm (inclusive). Vital signs criteria at each check-in and the pre-dose measurements will be at the Investigator's discretion.
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- Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
- Subjects (including those who have had a documented vasectomy) must be using a double-barrier local contraception (i.e., spermicidal gel plus condom) when engaging in sexual activity with women of childbearing potential while on study medication and for 28 days after the last dose of study medication.
- Subjects must refrain from sperm donations while on study drug, for the entire duration of the study, and for 28 days after the last dose of study drug.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, including the presence of laboratory abnormalities, that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Any serious medical condition, clinically significant laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
- Recent history within 3 years of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological or other major disorders.
- Used any prescribed systemic or topical medication within 30 days of the first dose administration.
- Used any non-prescribed systemic (including herbal medicines, e.g. St. John's Wort) or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements)
- Subjects who have any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME).
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- Exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration or currently enrolled in any investigational trials.
- Donated blood or plasma within 8 weeks preceding the first dose administration.
- History of multiple drug allergies.
- Any clinically significant allergic disease (excluding nonactive hay fever).
- History of drug abuse of at least 2 years prior to dosing, or positive drug screening test due to illicit drugs.
- History of alcohol abuse of at least 2 years prior to dosing, or positive alcohol screen.
- Smokers or users of other tobacco products (e.g., chewing tobacco, or those using nicotine-containing products (i.e., patches, gum) in the 3 months prior to screening, or positive urine cotinine test.
- Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or tests positive for HIV (human immunodeficiency virus) antibodies at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Dose, Four-Way Crossover, Bioavailability Study of Three Formulations of Decitabine/Tetrahydrouridine (THU) Combination Modified Release Capsules (5 mg/250 mg) in Healthy and Fasting Adults
To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3 modified release formulations in healthy subjects.
Read the detailed description
This is an open-label, randomized, single-dose per period, four-period, crossover study to evaluate relative bioavailability of decitabine in three newly formulated THU and decitabine combination capsules in comparison to 3 capsules of THU followed 1 hour later by 3 capsules of decitabine.
- Conditions
- Healthy
- Being tested
- Decitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Tetrahydrouridine
Combination drugs containing decitabine and tetrahydrouridine
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | 3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation A) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. Receives: Drug: Decitabine |
| Formulation B | Experimental | 3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation B) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. Receives: Drug: Decitabine |
| Formulation C | Experimental | 3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation C) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. Receives: Drug: Decitabine |
| Reference Formulation | Active comparator | 3 capsules of THU (250 mg per capsule) given as a single oral dose with approximately 240 mL of ambient temperature water, followed by a single oral dose of 3 capsules of decitabine (5 mg per capsule) given 1 hour later with approximately 240 mL of ambient temperature water. Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Decitabine
Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration of Decitabine
Measured: 24 hours
Decitabine plasma concentration
Maximum concentration (Cmax) of Decitabine in plasma
Measured: 24 hours
Pharmacokinetics of Tetrahydrouridine
Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration of THU
Measured: 24 hours
Secondary outcomes (1)
Safety of Decitabine and Tetrahydrouridine
Safety of single dose as measured by adverse event reporting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start3 Apr 2019
- Primary completion2 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Four-way crossover, single dose with a 7 days washout period in between periods
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpiDestiny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia A Zamora, MD, Principal investigator, Worldwide Clinical Trials Early Phase Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828084
- Sponsor's protocol ID
- EPI-01-CP.001
- Acronym
- EPI01
- Status last verified
- May 2019
- First submitted
- 31 Jan 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Four-Way Crossover, Bioavailability Study of Three Formulations of Decitabine/Tetrahydrouridine (THU) Combination Modified Release Capsules (5 mg/250 mg) in Healthy and Fasting Adults
- ClinicalTrials.gov ID
- NCT03828084
- Acronym / sponsor ID
- EPI01 / EPI-01-CP.001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EpiDestiny, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 4 Feb 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.
To study the pharmacokinetic profiles of decitabine and tetrahydrouridine (THU) from 3 modified release formulations in healthy subjects.
Detailed description
This is an open-label, randomized, single-dose per period, four-period, crossover study to evaluate relative bioavailability of decitabine in three newly formulated THU and decitabine combination capsules in comparison to 3 capsules of THU followed 1 hour later by 3 capsules of decitabine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four-way crossover, single dose with a 7 days washout period in between periods
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: Decitabine3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation A) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. |
| Formulation B | Experimental | Drug: Decitabine3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation B) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. |
| Formulation C | Experimental | Drug: Decitabine3 test capsules of combination decitabine/THU (5 mg/250 mg per capsule; Formulation C) given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water. |
| Reference Formulation | Active comparator | Drug: Decitabine3 capsules of THU (250 mg per capsule) given as a single oral dose with approximately 240 mL of ambient temperature water, followed by a single oral dose of 3 capsules of decitabine (5 mg per capsule) given 1 hour later with approximately 240 mL of ambient temperature water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Must understand and voluntarily sign a written ICF prior to any study related procedures being performed and be able to adhere to restrictions and examination schedules.
- Must be able to communicate with the investigator, and to understand and comply with the requirements of the study.
- Healthy male volunteers from any race between 18 to 50 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.
- Must have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 and 100 kg (132 to 220 lb), inclusive, at screening.
- Subject's clinical laboratory test results have no clinically significant findings, in the opinion of the Investigator.
Key exclusion criteria (14 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, including the presence of laboratory abnormalities, that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Any serious medical condition, clinically significant laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
- Recent history within 3 years of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological or other major disorders.
- Used any prescribed systemic or topical medication within 30 days of the first dose administration.
- Used any non-prescribed systemic (including herbal medicines, e.g. St. John's Wort) or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements)
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 |
|---|---|---|
| DecitabineAlso: TetrahydrouridineCombination drugs containing decitabine and tetrahydrouridine | Drug | Formulation A, Formulation B, Formulation C, Reference Formulation |
Primary outcome
Pharmacokinetics of Decitabine
Time frame: 24 hours
Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration of Decitabine
Decitabine plasma concentration
Time frame: 24 hours
Maximum concentration (Cmax) of Decitabine in plasma
Pharmacokinetics of Tetrahydrouridine
Time frame: 24 hours
Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration of THU
1 secondary outcome
Safety of Decitabine and Tetrahydrouridine
Time frame: 24 hours
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 9 May 2019.
- To participate in a Worldwide clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Cynthia A Zamora, MD principal investigator
Worldwide Clinical Trials Early Phase Services, LLC
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 Decitabine in people with Healthy, run by EpiDestiny, Inc. 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 14 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 9 May 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?
Pharmacokinetics of Decitabine (time frame: 24 hours). The study lists 3 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 9 May 2019.