NCT04310527

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, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Enasidenib	Enasidenib

Timeline

• Start date: 2019-10-09
• Primary completion: 2019-11-27
• Completion: 2019-12-09
• First posted: 2020-03-17
• Last updated: 2020-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study