CClinicalTrials.gg
CompletedNCT01733875Updated Nov 12, 2019

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

A Phase 1 interventional study of CC-220 0.03 mg and CC-220 0.1 mg in Healthy, sponsored by Celgene. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-12.

Sponsored by Celgene · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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

Read the detailed description

This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled, ascending-dose study. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow-up visit. There will be a total of 7 cohorts, each of which consists of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 2 subjects will receive placebo depending on the randomization schedule. A single dose will be administered to each subject. This study design allows safety and tolerability data to be gathered in a stepwise fashion. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is an open-label, randomized, 2-period, 2-way crossover study. During the course of Part 2, 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 visit. A total of 10 subjects will receive a single dose of 1 mg CC-220 in each of 2 study periods, once without food and once with food, depending on the treatment sequence to which they are randomized. The CC-220 dose in each study period will be separated by a washout of 11 to 14 days.

02

Conditions studied

  • Healthy

Keywords

  • Safety
  • Pharmacokinetics
  • Food effect
  • Healthy subjects
03

In context

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Must understand and voluntarily sign a written informed consent document prior to any study related procedures being performed.
  2. Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
  3. Healthy male or female of any race between 18 to 55 years of age (inclusive) at the time of signing the informed consent document, and in good health as determined by a physical exam.
  4. For males:

    1. Agree to use barrier contraception not made of natural (animal) membrane [for example, latex or polyurethane condoms are acceptable]) when engaging in sexual activity with a female of childbearing potential while on study medication, and for at least 28 days after the last dose of study medication.

      For females:

    2. Female subjects must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of \< 30 pg/mL and follicle stimulating hormone level of > 40 IU/L at screening).
  5. Must have a body mass index between 18 and 33 kg/m2 (inclusive).
  6. Clinical laboratory tests must be within normal limits or acceptable to the investigator.
  7. Subject must be afebrile, with supine systolic blood pressure: 90 to 140 mmHg, supine diastolic blood pressure: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm.
  8. Must have a normal or clinically acceptable 12-lead electrocardiogram at screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.

Exclusion criteria

Exclusion Criteria:

  1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
  2. Any condition which places the subject at unacceptable risk if he or she were to participate in the study, or confounds the ability to interpret data from the study.
  3. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration, unless sponsor agreement is obtained.
  4. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless sponsor agreement is obtained.
  5. Used cytochrome P450, sub-family 3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
  6. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, for example, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
  7. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
  8. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
  9. History of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive alcohol screen.
  10. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen or hepatitis C antibodies, or have a positive result to the test for human immunodeficiency virus antibodies at screening.
  11. Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
  12. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
  13. Vaccination within 30 days of dosing or plans to receive vaccination within 30 days after dosing. Systemic infection within 30 days of dosing.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    CC-220 0.03 mg

    Drug: CC-220 0.03 mg

  • Experimental
    CC-220 0.1 mg

    Drug: CC-220 0.1 mg

  • Experimental
    CC-220 0.3 mg

    Drug: CC-220 0.3 mg

  • Experimental
    CC-220 1 mg

    Drug: CC-220 1 mg

  • Experimental
    CC-220 2 mg

    Drug: CC-220 2 mg

  • Experimental
    Placebo

    In each arm, 6 subjects will receive a dose of CC-220 and 2 subjects will receive placebo depending on the randomization schedule.

    Drug: Placebo

  • Experimental
    CC-220 4 mg

    Drug: CC-220

  • Experimental
    CC-220 6 mg

    Drug: CC-220

  • Experimental
    CC-220 1 mg (Part 2 only)

    Drug: CC-220

Interventions

  • DrugCC-220 0.03 mg

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

  • DrugCC-220 0.1 mg

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

  • DrugCC-220 0.3 mg

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

  • DrugCC-220 1 mg

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

  • DrugCC-220 2 mg

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

  • DrugPlacebo

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

  • DrugCC-220

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

  • DrugCC-220

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

  • DrugCC-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

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Number of study participants with Adverse Events

    Time frame: Up to 5 months overall

  2. Concentrations of CC-220 and its R-enantiomer in plasma (Part 2 only)

    Blood samples will be collected at pre-specified times to determine levels of CC-220 free base and its R-enantiomer in plasma

    Time frame: Up to 3 days in each period

Secondary outcomes

  1. Concentrations of CC-220 and its R-enantiomer in plasma (Part 1 only)

    Blood samples will be collected at pre-specified times to determine levels of CC-220 free base and its R-enantiomer in plasma

    Time frame: Up to 3 days

  2. PK-Cmax

    Cmax: Maximum observed plasma concentration

    Time frame: Up to 3 days

  3. PK-Tmax

    Time to Maximum Plasma Concentration

    Time frame: Up to 3 days

  4. PK-AUC 0-∞

    Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Time frame: Up to 3 days

  5. PK-AUC 0-t

    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

    Time frame: Up to 3 days

  6. PK-t1/2,z

    Terminal-phase elimination half-life

    Time frame: Up to 3 days

  7. PK-CL/F

    Apparent total plasma clearance when dosed orally

    Time frame: Up to 3 days

  8. PK-Vz/F

    Apparent total volume of distribution when dosed orally, based on the terminal phase

    Time frame: Up to 3 days

  9. PK-Ae48

    Cumulative amount of drug excreted unchanged in urine through 48 hours postdose

    Time frame: Up to 3 days

  10. PK-fe48

    Cumulative percentage of the administered dose excreted unchanged in urine through 48 hours postdose

    Time frame: Up to 3 days

  11. PK-CLr

    Renal clearance

    Time frame: Up to 3 days

07

Study locations

1 site
  • Covance Clinical Research Unit
    Madison, Wisconsin 53704, United States
08

References and documents

Publications

  • Schafer PH, Ye Y, Wu L, Kosek J, Ringheim G, Yang Z, Liu L, Thomas M, Palmisano M, Chopra R. Cereblon modulator iberdomide induces degradation of the transcription factors Ikaros and Aiolos: immunomodulation in healthy volunteers and relevance to systemic lupus erythematosus. Ann Rheum Dis. 2018 Oct;77(10):1516-1523. doi: 10.1136/annrheumdis-2017-212916. Epub 2018 Jun 26. PubMed 29945920 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01733875
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Nov 27, 2012
Start date
Nov 1, 2012
Primary completion
Oct 9, 2013
Completion
Oct 9, 2013
Last update
Nov 12, 2019

Study contacts

Daniel Weiss, MD
study director · Celgene Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion