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2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects

NCT01733875 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-11-12

No results posted yet for this study

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects

Conditions

  • Healthy

Interventions

DRUG

CC-220 0.03 mg

A single dose of CC-220 0.03 mg will be administered orally once a day.

DRUG

CC-220 0.1 mg

A single dose of CC-220 0.1 mg will be administered orally once a day.

DRUG

CC-220 0.3 mg

A single dose of CC-220 0.3 mg will be administered orally once a day.

DRUG

CC-220 1 mg

A single dose of CC-220 1 mg will be administered orally once a day.

DRUG

CC-220 2 mg

A single dose of CC-220 2 mg will be administered orally once a day.

DRUG

Placebo

A single dose of placebo will be administered orally once a day.

DRUG

CC-220

CC-220 4 mg will be administered orally once a day

DRUG

CC-220

CC-220 6 mg will be administered orally once a day

DRUG

CC-220

CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Daniel Weiss, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2013-10-09
Completion
2013-10-09

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 NCT01733875 on ClinicalTrials.gov