Healthy Volunteers Clinical Trial
Official title:
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
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.
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.
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