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3-part Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of CC-220 and Relative Bioavailability of a Formulated CC-220 Capsule

NCT02034773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-01-13

No results posted yet for this study

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated CC-220 capsule

Conditions

  • Healthy Volunteers

Interventions

DRUG

CC-220

CC-220 0.3mg will be administered once daily for 14 days

DRUG

CC-220

CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination

DRUG

CC-220

CC-220 0.3mg will be administered once daily for 28 days

DRUG

CC-220

CC-220 1mg will be administered once daily for 7 days on 2 separate occasions, with a 7-day washout in between, for a total of 14 days of dosing

DRUG

Placebo

Placebo will be administered once daily for up to 28 days

DRUG

CC-220

CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)

DRUG

CC-220

CC-220 1mg (once every 7 days for 28 days)

DRUG

CC-220

CC-220 1mg will be administered as a single dose in each of 2 study periods; once as a formulated capsule and once as two reference capsules

Sponsors & Collaborators

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Daniel Weiss, MD · Celgene

  • Debra Mandarino, MD · Covance

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02034773 on ClinicalTrials.gov