- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086238
Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects
January 21, 2020 updated by: EpiDestiny, Inc.
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trial
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Formulation A Fasted
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
Experimental: Formulation A Fed
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
Other: Formulation B Fasted
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
Experimental: Formulation B Fed
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
Other: Formulation C Fasted
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
Experimental: Formulation C Fed
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.
|
Capsules containing a combination of decitabine and THU
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Decitabine plasma concentration
Time Frame: 24 hours
|
Maximum concentration (Cmax) of Decitabine in plasma
|
24 hours
|
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
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of decitabine and tetrahydrouridine
Time Frame: 24 hours
|
The number of subjects reporting adverse events such as nausea and headache.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia A Zamora, MD, Worldwide Clinical Trails Early Phase Services, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2019
Primary Completion (Actual)
November 21, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
September 10, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 11, 2019
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPI01-CP.002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Decitabine
-
Otsuka Beijing Research InstituteRecruitingMyelodysplastic SyndromesChina
-
Chinese PLA General HospitalRecruitingHodgkin Lymphoma | Anti-PD-1 Antibody ResistantChina
-
Astex Pharmaceuticals, Inc.CompletedAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myelomonocytic LeukemiaUnited States, Canada, Spain, Hungary, Austria, Czechia, France, Germany, Italy, United Kingdom
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkRecruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterGenentech, Inc.; Astex Pharmaceuticals, Inc.RecruitingChronic Myelomonocytic Leukemia | Myelodysplastic SyndromeUnited States
-
Shandong UniversityUnknownMyelodysplastic SyndromesChina
-
M.D. Anderson Cancer CenterRecruitingAcute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent Acute Biphenotypic Leukemia | Refractory Acute Biphenotypic LeukemiaUnited States
-
Eisai Inc.TerminatedMyelodysplastic SyndromesUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Astex Pharmaceuticals, Inc.RecruitingChronic Phase Chronic Myelogenous Leukemia | Philadelphia Chromosome Positive | BCR-ABL1 Positive Chronic Myelogenous Leukemia | BCR-ABL1 PositiveUnited States