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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

NCT03135509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

CC-220

CC-220 gelatin capsules

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Maria Palmisano, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2017-06-28
Completion
2017-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135509 on ClinicalTrials.gov