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

Celgene1 site in 1 country28 target enrollmentOctober 9, 2019

ConditionsHealthy Volunteers

InterventionsEnasidenib

DrugsEnasidenib

Overview

Phase: Phase 1
Intervention: Enasidenib
Conditions: Healthy Volunteers
Sponsor: Celgene
Enrollment: 28
Locations: 1
Primary Endpoint: Pharmacokinetics - Vz/F
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 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.

Registry

clinicaltrials.gov

Start Date

October 9, 2019

End Date

December 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•a. 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).
•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).

Exclusion Criteria

•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;
•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
•Subject has consumed herbal remedies or dietary supplements containing St. John's Wort, in the 3 weeks before Day
•Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion.