VolunteersPhase 1NCT02922946
Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat
A Phase 1 study testing Entinostat in people with Volunteers and Healthy Volunteers, run by Syndax Pharmaceuticals at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers, Healthy Volunteers, Human Volunteers
- What is being tested?
- Entinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2016to 26 Jun 2017
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 19-55 years of age at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to first dose and throughout the study.
- Body mass index of ≥ 18.5 at screening.
- Medically healthy with no significant medical history, physical examination, laboratory values, vital signs, or ECGs. Liver function tests and serum bilirubin must be ≤ the upper limit of normal. Platelets, hemoglobin, and hematocrit must be > the lower limit of normal at screening.
- Females of non-childbearing potential must have undergone sterilization procedures as noted in protocol at least 6 months prior to dose.
- Non-vasectomized male subjects must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dose of study drug.
- Male subjects must agree not to donate sperm from the first dose until 90 days beyond dose of study drug.
- Understands the study procedures in the informed consent form and be willing and able to comply with the protocol.
Who cannot join
- Mentally or legally incapacitated or has significant emotional problems at screening or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee.
- History of presence of alcoholism or drug abuse within the past 2 years prior to dose.
- History or presence of clinically significant cancer, cardiovascular disorders, acute or chronic gastrointestinal conditions in the opinion of the PI.
- Females of childbearing potential.
Show all 20Show fewer
- Females with a positive pregnancy test or lactating.
- Positive urine drug or alcohol results are screening or each check-in.
- Positive urine cotinine at screening.
- Positive results are screening for HIV, hepatitis B surface antigen, or hepatitis C virus
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- Seated heart rate lower than 40 bpm or higher than 99 bpm at screening.
- QTcB interval (correction value of the interval between the Q and T waves on the ECG tracing using the Bazett Correction Formula) > 460 msec for males or > 480 msec for females or has ECG findings deemed abnormal by the PI or designee.
- Estimated creatinine clearance < 90 mL/min at screening.
- Unable to refrain from or anticipates the use of any prescription or non-prescription medications and any drugs known to be significant inhibitors or CYP (Cytochromes 450) enzymes and/or P-gp.
- Has been on a diet incompatible with the on-study diet within 28 days prior to dose and throughout the study in the opinion of the PI or designee.
- Is lactose intolerant.
- Donation of blood or significant blood loss within 56 days prior to dose.
- Plasma donation within 7 days prior to dose.
- Participation in another clinical study 28 days prior to dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Stage, Open-Label, Randomized, Single-Dose, Crossover Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.
Read the detailed description
This is a 2-stage food effect (timing of the meal) study. A total of 48 subjects will be dosed if Stage 2 is conducted.
Stage 1 will be conducted as an open-label, randomized, 2-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions.
If preliminary results in Stage 1 indicate that the timing of a meal exhibits significant effect on the bioavailability of entinostat, then Stage 2 will be conducted which will investigate the effect of a meal either before or after dosing of entinostat on entinostat PK.
Stage 2 will be conducted as an open-label, randomized, 3-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions.
- Conditions
- Volunteers, Healthy Volunteers, Human Volunteers, Normal Volunteers
- Being tested
- Entinostat
- Keywords
- entinostat, Histone Deacetylase Inhibitor, HDAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntinostatDrug
Also called SNDX-275, MS-275
HDAC (histone deacetylase) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Entinostat 5mg in 2-Way Crossover | Experimental | Treatment A: 5mg entinostat following an overnight fast and followed by a 4-hour fast.
Treatment B: 5mg entinostat 2 hours after the completion of a meal and followed by a 1-hour fast. Receives: Drug: Entinostat |
| Entinostat 5mg in 3-Way Crossover | Experimental | Treatment C: 5mg entinostat following an overnight fast and followed by a 4-hour fast.
Treatment D: 5mg entinostat following an overnight fast and 1 hour before the start of a meal.
Treatment E: 5mg entinostat 2 hours after the completion of a meal and followed by a 4-hour fast. Receives: Drug: Entinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t (area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) for entinostat under fed and fasting conditions
Measured: Pre-dose through Day 22
AUC0-inf (area under the concentration-time curve, from time 0 extrapolated to infinity) for entinostat under fed and fasting conditions
Measured: Pre-dose through Day 22
Cmax (maximum observed concentration) of entinostat under fed and fasting conditions
Measured: Pre-dose through Day 22
AUC%extrap (percent of AUC0-inf extrapolated) of entinostat under fed and fasting conditions
Measured: Pre-dose through Day 22
Tmax (time to reach maximum observed concentration) of entinostat under fed and fasted conditions
Measured: Pre-dose through Day 22
Kel (apparent terminal elimination rate constant) of entinostat under fed and fasted conditions
Measured: Pre-dose through Day 22
T1/2 (apparent terminal elimination half-life) of entinostat under fed and fasted conditions
Measured: Pre-dose through Day 22
Changes from baseline in physical exam
Measured: Baseline through Day 1
Changes from baseline in vital signs
Measured: Baseline through Day 22
Changes from baseline in ECG results
Measured: Baseline through Day 22
Changes from baseline in adverse events
Measured: Baseline through 14 days after last sample collection
Changes from baseline in clinical laboratory tests
Measured: Baseline through Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start11 Oct 2016
- Primary completion20 May 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Sterling, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922946
- Sponsor's protocol ID
- SNDX-275-0180
- Status last verified
- Aug 2018
- First submitted
- 30 Sep 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be reviewed throughout the study by the sponsor, clinical research organization assisting with serious adverse event management, and routine monitoring to safeguard the interests of the trial subjects and to assess the safety of the interventions administered during the trial.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Stage, Open-Label, Randomized, Single-Dose, Crossover Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02922946
- Acronym / sponsor ID
- SNDX-275-0180
- Conditions
- Volunteers, Healthy Volunteers, Human Volunteers, Normal Volunteers
- Keywords
- entinostat, Histone Deacetylase Inhibitor, HDAC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.
Detailed description
This is a 2-stage food effect (timing of the meal) study. A total of 48 subjects will be dosed if Stage 2 is conducted.
Stage 1 will be conducted as an open-label, randomized, 2-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions.
If preliminary results in Stage 1 indicate that the timing of a meal exhibits significant effect on the bioavailability of entinostat, then Stage 2 will be conducted which will investigate the effect of a meal either before or after dosing of entinostat on entinostat PK.
Stage 2 will be conducted as an open-label, randomized, 3-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entinostat 5mg in 2-Way Crossover | Experimental | Drug: EntinostatTreatment A: 5mg entinostat following an overnight fast and followed by a 4-hour fast. Treatment B: 5mg entinostat 2 hours after the completion of a meal and followed by a 1-hour fast. |
| Entinostat 5mg in 3-Way Crossover | Experimental | Drug: EntinostatTreatment C: 5mg entinostat following an overnight fast and followed by a 4-hour fast. Treatment D: 5mg entinostat following an overnight fast and 1 hour before the start of a meal. Treatment E: 5mg entinostat 2 hours after the completion of a meal and followed by a 4-hour fast. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults 19-55 years of age at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to first dose and throughout the study.
- Body mass index of ≥ 18.5 at screening.
- Medically healthy with no significant medical history, physical examination, laboratory values, vital signs, or ECGs. Liver function tests and serum bilirubin must be ≤ the upper limit of normal. Platelets, hemoglobin, and hematocrit must be > the lower limit of normal at screening.
- Females of non-childbearing potential must have undergone sterilization procedures as noted in protocol at least 6 months prior to dose.
Key exclusion criteria (20 listed)
- Mentally or legally incapacitated or has significant emotional problems at screening or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee.
- History of presence of alcoholism or drug abuse within the past 2 years prior to dose.
- History or presence of clinically significant cancer, cardiovascular disorders, acute or chronic gastrointestinal conditions in the opinion of the PI.
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 |
|---|---|---|
| EntinostatAlso: SNDX-275, MS-275HDAC (histone deacetylase) inhibitor | Drug | Entinostat 5mg in 2-Way Crossover, Entinostat 5mg in 3-Way Crossover |
Primary outcome
AUC0-t (area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) for entinostat under fed and fasting conditions
Time frame: Pre-dose through Day 22
AUC0-inf (area under the concentration-time curve, from time 0 extrapolated to infinity) for entinostat under fed and fasting conditions
Time frame: Pre-dose through Day 22
Cmax (maximum observed concentration) of entinostat under fed and fasting conditions
Time frame: Pre-dose through Day 22
AUC%extrap (percent of AUC0-inf extrapolated) of entinostat under fed and fasting conditions
Time frame: Pre-dose through Day 22
Tmax (time to reach maximum observed concentration) of entinostat under fed and fasted conditions
Time frame: Pre-dose through Day 22
Kel (apparent terminal elimination rate constant) of entinostat under fed and fasted conditions
Time frame: Pre-dose through Day 22
T1/2 (apparent terminal elimination half-life) of entinostat under fed and fasted conditions
Time frame: Pre-dose through Day 22
Changes from baseline in physical exam
Time frame: Baseline through Day 1
Changes from baseline in vital signs
Time frame: Baseline through Day 22
Changes from baseline in ECG results
Time frame: Baseline through Day 22
Changes from baseline in adverse events
Time frame: Baseline through 14 days after last sample collection
Changes from baseline in clinical laboratory tests
Time frame: Baseline through Day 1
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 16 Aug 2018.
- Individual participant dataSharing planned: No. Data will be reviewed throughout the study by the sponsor, clinical research organization assisting with serious adverse event management, and routine monitoring to safeguard the interests of the trial subjects and to assess the safety of the interventions administered during the trial.
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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.
Laura Sterling, MD principal investigator
Celerion
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 Entinostat in people with Volunteers and Healthy Volunteers, run by Syndax Pharmaceuticals 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 8 inclusion and 20 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 16 Aug 2018. 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?
AUC0-t (area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) for entinostat under fed and fasting conditions (time frame: Pre-dose through Day 22). The study lists 12 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 16 Aug 2018.