Healthy VolunteersPhase 1NCT04310527
Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults
A Phase 1 study testing Enasidenib in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is an open-label, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States. This study will evaluate the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the reference tablet formulation, when taken in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Enasidenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2019to 9 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
- Female subjects NOT of childbearing potential must:
- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or be postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at Screening).
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- Females of childbearing potential (FCBP)1 may participate, providing they meet the following conditions:
- Agree to practice true abstinence2 from sexual intercourse or to use highly effective contraceptive methods (eg, combined [containing estrogen and progestogen] or progestogen-only associated with inhibition of ovulation, oral, injectable, intravaginal ring (e.g. vaginal hormonal ring), patch, or implantable hormonal contraceptive; bilateral tubal occlusion; intra-uterine device; intrauterine hormone-releasing system; or male partner sterilization [note that vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the Females of childbearing potential (FCBP) trial participant and that the vasectomized partner has received medical assessment of the surgical success]) at screening and throughout the study, and for 2 months following the last study treatment;
- Have a negative serum β-subunit of human chorionic gonadotropin (β-hCG) pregnancy test (sensitivity of at least 25 mIU/mL) at Screening; and
- Have a negative serum β-hCG pregnancy test (sensitivity of at least 25 mIU/mL) within 72 hours prior to the start of study treatment in the Treatment Phase (note that the screening serum pregnancy test can be used as the test prior to the start of study treatment in the Treatment Phase if it is performed within the 72-hour timeframe).
- Male subjects must:
- Practice true abstinence3 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or FCBP while participating in the study and for at least 2 months after the last dose of Investigational product (IP), even if he has undergone a successful vasectomy.
- Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at Screening.
- Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities determined by medical history, PE, vital signs, 12-lead ECG, and clinical laboratory evaluation (hematology, clinical chemistry, and urinalysis) that are reasonably likely to interfere with the subject's participation in, or ability to complete the study as assessed by the Investigator.
- Subject vital signs are as follows:
- Tympanic body temperature:35.0 - 37.5°C.
- Supine blood pressure (BP) after at least 5 minutes supine rest: i. Systolic BP: 90 - 140 mmHg ii. Diastolic BP: 40 - 90 mmHg b. Supine heart rate (after at least 5 minutes of rest):
- 45 - 90 beats per minute (measured during vital sign assessment)
- Subject has a normal or clinically acceptable 12-lead ECG at Screening.
- In addition:
- If male, subject has a QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤ 430 msec at Screening. ii. If female, subject has a QTcF value ≤ 450 msec at Screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness as determined by medical history, Physical examination (PE), vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory evaluation (hematology, clinical chemistry, and urinalysis) that would place the subject at unacceptable risk or prevent the subject from participating in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has a history of multiple (ie, 2 or more) or severe drug allergies.
- Subject has been:
- previously exposed to enasidenib or;
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- has been exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
- Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) except those permitted in within 14 days prior to Day 1.
- Subject has consumed herbal remedies or dietary supplements containing St. John's Wort, in the 3 weeks before Day 1.
- Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion.
- Chronic or permanent conditions such as bariatric procedures, extensive bowel resections, irritable bowel syndrome, etc. are exclusionary at any time prior to Screening.
- Acute conditions such as dysentery or acute gastroenteritis are exclusionary if they resolved less than 14 days before Screening.
- Appendectomy and cholecystectomy are acceptable.
- Subject has a history of drug or alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive Screening or Day -1 test reflecting consumption of illicit drugs or alcohol.
- Subject is known to have any viral hepatitis infection (including carrier state) or has a positive result to the tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibodies at Screening.
- Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Subject is part of the clinical staff personnel or a family member of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-Center, Randomized, Three-period, Two-Sequence Crossover Study to Assess Relative Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and to Assess the Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adult SubjectsHEALTHY ADULT SUBJECTS
This is an open-label, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States. This study will evaluate the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the reference tablet formulation, when taken in the fasted state. This study will also evaluate the Pharmacokinetics (PK) of the enasidenib sprinkle formulation after a single oral dose in the fed state to assess the food effect. The study will consist of a Screening phase, a Treatment phase, and a Follow-up phone call. Approximately 28 healthy adult subjects (males or non-pregnant females) will be enrolled.
- Conditions
- Healthy Volunteers
- Being tested
- Enasidenib
- Keywords
- Enasidenib, CC-90007, pharmacokinetics, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnasidenibDrug
Enasidenib
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Administration of enasidenib fasted | Experimental | A single oral 100 mg dose of enasidenib reference formulation will be given under fasted condition. Receives: Drug: Enasidenib |
| Treatment B: Administration of enasidenib fasted | Experimental | A single oral 100 mg dose of enasidenib test formulation will be given under fasted condition. Receives: Drug: Enasidenib |
| Treatment C: Administration of ensidenib fed | Experimental | A single oral 100 mg dose of enasidenib test formulation will be given under fed condition. Receives: Drug: Enasidenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Observed maximum concentration
Measured: UP to approximately 14 days
Pharmacokinetics - AUC0-∞
Area under the concentration-time curve calculated from time zero to infinity
Measured: UP to approximately 14 days
Pharmacokinetics - AUC0-t
Area under the concentration-time curve calculated from time zero to the last measured time point
Measured: UP to approximately 14 days
Pharmacokinetics - Tmax
Time to Cmax
Measured: UP to approximately 14 days
Pharmacokinetics - t½
Terminal elimination half-life
Measured: UP to approximately 14 days
Pharmacokinetics - CL/F
Apparent clearance of drug from plasma after extravascular administration
Measured: UP to approximately 14 days
Pharmacokinetics - Vz/F
Apparent volume of distribution during the terminal phase
Measured: UP to approximately 14 days
Secondary outcomes (1)
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start9 Oct 2019
- Primary completion27 Nov 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310527
- Sponsor's protocol ID
- CC-90007-CP-006
- Other IDs
- U1111-1243-9124
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-Center, Randomized, Three-period, Two-Sequence Crossover Study to Assess Relative Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and to Assess the Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adult SubjectsHEALTHY ADULT SUBJECTS
- ClinicalTrials.gov ID
- NCT04310527
- Acronym / sponsor ID
- CC-90007-CP-006
- Conditions
- Healthy Volunteers
- Keywords
- Enasidenib, CC-90007, pharmacokinetics, Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 17 Mar 2020 (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, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States. This study will evaluate the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the reference tablet formulation, when taken in the fasted state. This study will also evaluate the Pharmacokinetics (PK) of the enasidenib sprinkle formulation after a single oral dose in the fed state to assess the food effect. The study will consist of a Screening phase, a Treatment phase, and a Follow-up phone call. Approximately 28 healthy adult subjects (males or non-pregnant females) will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Administration of enasidenib fasted | Experimental | Drug: EnasidenibA single oral 100 mg dose of enasidenib reference formulation will be given under fasted condition. |
| Treatment B: Administration of enasidenib fasted | Experimental | Drug: EnasidenibA single oral 100 mg dose of enasidenib test formulation will be given under fasted condition. |
| Treatment C: Administration of ensidenib fed | Experimental | Drug: EnasidenibA single oral 100 mg dose of enasidenib test formulation will be given under fed condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
- Female subjects NOT of childbearing potential must:
- Females of childbearing potential (FCBP)1 may participate, providing they meet the following conditions:
Key exclusion criteria (17 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness as determined by medical history, Physical examination (PE), vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory evaluation (hematology, clinical chemistry, and urinalysis) that would place the subject at unacceptable risk or prevent the subject from participating in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has a history of multiple (ie, 2 or more) or severe drug allergies.
- Subject has been:
- Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) except those permitted in within 14 days 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 |
|---|---|---|
| EnasidenibEnasidenib | Drug | Treatment A: Administration of enasidenib fasted, Treatment B: Administration of enasidenib fasted, Treatment C: Administration of ensidenib fed |
Primary outcome
Pharmacokinetics - Cmax
Time frame: UP to approximately 14 days
Observed maximum concentration
Pharmacokinetics - AUC0-∞
Time frame: UP to approximately 14 days
Area under the concentration-time curve calculated from time zero to infinity
Pharmacokinetics - AUC0-t
Time frame: UP to approximately 14 days
Area under the concentration-time curve calculated from time zero to the last measured time point
Pharmacokinetics - Tmax
Time frame: UP to approximately 14 days
Time to Cmax
Pharmacokinetics - t½
Time frame: UP to approximately 14 days
Terminal elimination half-life
Pharmacokinetics - CL/F
Time frame: UP to approximately 14 days
Apparent clearance of drug from plasma after extravascular administration
Pharmacokinetics - Vz/F
Time frame: UP to approximately 14 days
Apparent volume of distribution during the terminal phase
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
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 17 Mar 2020.
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Screening Protocol
Pain
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.
Leon Carayannopoulos, MD study director
Celgene
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 Enasidenib in people with Healthy Volunteers, run by Celgene 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 21 inclusion and 17 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 17 Mar 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?
Pharmacokinetics - Cmax (time frame: UP to approximately 14 days). The study lists 7 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 17 Mar 2020.