NCT03135509

A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects

A Phase 1, Open-label, Single-center Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments: * Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules. * Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.

Detailed description

The study will consist of 2 study periods. Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period, and a follow up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1, and will remain domiciled at the study center from Day -1 of Period 1 to Day 4 of Period 2. On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of each study period, each subject will receive 1 of 2 treatments according to the sequence in which he or she is randomized. Blood samples will be collected at prespecified times for PK, PD, and clinical laboratory safety tests. Urine samples will be collected at prespecified times for clinical laboratory safety tests. Safety will be monitored throughout the study. Safety evaluations will include AE reporting, review of concomitant medications and procedures, physical examinations (PEs), 12-lead ECGs, vital sign measurements, and clinical laboratory safety tests. Subjects will be discharged from the study center on Day 4 of Period 2 upon completion of scheduled study-related procedures and satisfactory safety review. Each subject will receive a follow-up telephone call within 5 to 7 days following discharge from the study center. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-220	CC-220 gelatin capsules

Timeline

• Start date: 2017-05-24
• Primary completion: 2017-06-28
• Completion: 2017-06-28
• First posted: 2017-05-01
• Last updated: 2017-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study