HealthyPhase 1NCT04086238

Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects

A Phase 1 study testing Decitabine in people with Healthy, run by EpiDestiny, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is to investigate the effect of a high fat meal on the pharmacokinetics of decitabine and THU in healthy adults when administered as a modified release formulation of the 2 drugs in combination. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy 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: 46 participants
Where: 1 siteUnited States
Study dates: 8 Oct 2019to 30 Nov 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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Understands and voluntarily signs a written Informed Consent Form prior to any study related procedures being performed and is able to adhere to restrictions and examination schedules.
Able to communicate with the investigator, and to understand and comply with the requirements of the study.
A healthy male or female from any race between 18 to 50 years of age (inclusive). If female, she meets at least one of the following criteria: Surgically sterile (hysterectomy, tubal ligation or bilateral oophorectomy); Or ≥1 year postmenopausal (will have a follicle-stimulating hormone test performed at screening to confirm postmenopausal status)
A body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a minimum weight of 50 kg at screening.
Subjects must be free of any clinically significant disease that would interfere with the study evaluations, and be in good health as determined by past medical history, physical examination, and ECG at screening.
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).
Male subjects (including those who have had a documented vasectomy) must use 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. They must also agree to refrain from sperm donations while on study drug, for the entire duration of the study, and for at least 28 days after the last dose of study drug.

Who cannot join

History (within 3 years prior to screening) 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 Informed Consent Form.
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), including a past cholecystectomy.
Exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration or currently enrolled in any investigational trials.

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Donated blood or plasma within 8 weeks preceding the first dose administration.
History of multiple drug allergies.
Any clinically significant allergic disease (excluding nonactive hayfever).
History of drug abuse within 2 years prior to dosing, or a positive drug test at screening or either check-in.
History of alcohol abuse within 2 years prior to dosing, or a positive alcohol test at screening or either check-in.
Smokers or users of other tobacco products (e.g., chewing tobacco, or those using nicotine-containing products (i.e., patches, gum) within 3 months prior to screening, or a positive urine cotinine test at screening or either check-in.
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.
Subject must not consume beverages and foods containing grapefruit, broccoli, poppy seeds, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to the first dose of study medication until the end-of-study visit. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study investigator based on the potential for interaction with the study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trial
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Four-Period, Three-Block, Pharmacokinetic Study of Three Formulations of Decitabine/Tetrahydrouridine (THU) Combination Modified Release Capsules in Healthy Adults Under Fasting and Fed Conditions

Read the detailed description

This study is to evaluate the relative pharmacokinetics of oral decitabine and tetrahydrouridine (THU) after a high-fat, high-calorie (FDA standard) meal as compared to decitabine and THU under fasting conditions in healthy adult male and female subjects. In addition, this study is to compare the pharmacokinetic parameters between male and female subjects, and also to capture safety information for the decitabine and THU combination in healthy subjects after oral dosing.

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 EPI01, Tetrahydrouridine
Capsules containing a combination of decitabine and THU

Study groups in NCT04086238
Study group	Role	What they receive
Formulation A Fasted	Other	EPI01 Formulation A (moderate release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine
Formulation A Fed	Experimental	EPI01 Formulation A (moderate release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine
Formulation B Fasted	Other	EPI01 Formulation B (slow reelase): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine
Formulation B Fed	Experimental	EPI01 Formulation B (slow release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine
Formulation C Fasted	Other	EPI01 Formulation C (retarded release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine
Formulation C Fed	Experimental	EPI01 Formulation C (retarded release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water. Receives: Drug: Decitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Absorption 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
Absorption 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
The number of subjects reporting adverse events such as nausea and headache.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 201930 Nov 2019

First posted11 Sep 2019
Study start8 Oct 2019
Primary completion21 Nov 2019
Study completion30 Nov 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: Open-label, randomized, three-block, four-period study to evaluate the relative pharmacokinetics of three test formulations of decitabine and THU in a modified release THU and decitabine combination capsule (EPI01) in healthy male and female adults
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04086238
Sponsor's protocol ID: EPI01-CP.002
Status last verified: Sep 2019
First submitted: 10 Sep 2019
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Four-Period, Three-Block, Pharmacokinetic Study of Three Formulations of Decitabine/Tetrahydrouridine (THU) Combination Modified Release Capsules in Healthy Adults Under Fasting and Fed Conditions
ClinicalTrials.gov ID: NCT04086238
Acronym / sponsor ID: EPI01-CP.002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: EpiDestiny, Inc.Industry (pharma, biotech, devices)
Study start: 8 Oct 2019 (actual)
Primary completion: 21 Nov 2019 (actual)
Study completion: 30 Nov 2019 (actual)
First posted: 11 Sep 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Open-label, randomized, three-block, four-period study to evaluate the relative pharmacokinetics of three test formulations of decitabine and THU in a modified release THU and decitabine combination capsule (EPI01) in healthy male and female adults

Arm	Type	Receives
Formulation A Fasted	Other	Drug: DecitabineEPI01 Formulation A (moderate release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water.
Formulation A Fed	Experimental	Drug: DecitabineEPI01 Formulation A (moderate release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water.
Formulation B Fasted	Other	Drug: DecitabineEPI01 Formulation B (slow reelase): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water.
Formulation B Fed	Experimental	Drug: DecitabineEPI01 Formulation B (slow release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water.
Formulation C Fasted	Other	Drug: DecitabineEPI01 Formulation C (retarded release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fasting conditions. Single oral administration with 250mL of water.
Formulation C Fed	Experimental	Drug: DecitabineEPI01 Formulation C (retarded release): 3 capsules each containing decitabine (5 mg) and THU (250 mg) administered under fed conditions. Single oral administration with 250mL of water.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Understands and voluntarily signs a written Informed Consent Form prior to any study related procedures being performed and is able to adhere to restrictions and examination schedules.
Able to communicate with the investigator, and to understand and comply with the requirements of the study.
A healthy male or female from any race between 18 to 50 years of age (inclusive). If female, she meets at least one of the following criteria: Surgically sterile (hysterectomy, tubal ligation or bilateral oophorectomy); Or ≥1 year postmenopausal (will have a follicle-stimulating hormone test performed at screening to confirm postmenopausal status)
A body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a minimum weight of 50 kg at screening.
Subjects must be free of any clinically significant disease that would interfere with the study evaluations, and be in good health as determined by past medical history, physical examination, and ECG at screening.

Key exclusion criteria (14 listed)

History (within 3 years prior to screening) 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 Informed Consent Form.
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), including a past cholecystectomy.

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: EPI01, TetrahydrouridineCapsules containing a combination of decitabine and THU	Drug	Formulation A Fasted, Formulation A Fed, Formulation B Fasted, Formulation B Fed, Formulation C Fasted, Formulation C Fed

Primary outcome

Absorption 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
Absorption 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 22 Jan 2020.
Individual participant dataSharing planned: No. Undecided

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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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 Trails 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 7 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 22 Jan 2020. 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?

Absorption 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?

On the ClinicalTrials.gov record for NCT04086238.

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 22 Jan 2020.