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

NCT01733875 | Completed Phase 1

• 1 other identifier: CC-220-CP-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Safety; Pharmacokinetics; Food effect; Healthy subjects

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of study participants with Adverse Events

  Up to 5 months overall

• 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

  Up to 3 days in each period

Secondary Outcomes (11)

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

  Up to 3 days

• PK-Cmax

  Up to 3 days

• PK-Tmax

  Up to 3 days

• PK-AUC 0-∞

  Up to 3 days

• PK-AUC 0-t

  Up to 3 days

Study Arms (9)

CC-220 0.03 mg

EXPERIMENTAL

Drug: CC-220 0.03 mg

CC-220 0.1 mg

EXPERIMENTAL

Drug: CC-220 0.1 mg

CC-220 0.3 mg

EXPERIMENTAL

Drug: CC-220 0.3 mg

CC-220 1 mg

EXPERIMENTAL

Drug: CC-220 1 mg

CC-220 2 mg

EXPERIMENTAL

Drug: CC-220 2 mg

Placebo

EXPERIMENTAL

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

CC-220 4 mg

EXPERIMENTAL

Drug: CC-220

CC-220 6 mg

EXPERIMENTAL

Drug: CC-220

CC-220 1 mg (Part 2 only)

EXPERIMENTAL

Drug: CC-220

Interventions

CC-220 0.03 mg DRUG

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

CC-220 0.03 mg

CC-220 0.1 mg DRUG

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

CC-220 0.1 mg

CC-220 0.3 mg DRUG

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

CC-220 0.3 mg

CC-220 1 mg DRUG

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

CC-220 1 mg

CC-220 2 mg DRUG

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

CC-220 2 mg

Placebo DRUG

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

Placebo

CC-220 DRUG

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

CC-220 4 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must understand and voluntarily sign a written informed consent document prior to any study related procedures being performed.
• 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.
• 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.
• For males:
• 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:
• 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).
• Must have a body mass index between 18 and 33 kg/m2 (inclusive).
• Clinical laboratory tests must be within normal limits or acceptable to the investigator.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Used cytochrome P450, sub-family 3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
• Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, for example, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• 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.
• 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.
• 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.
• 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).
• Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
• Vaccination within 30 days of dosing or plans to receive vaccination within 30 days after dosing. Systemic infection within 30 days of dosing.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 29945920 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

iberdomide

Study Officials

• Daniel Weiss, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: October 9, 2013
• Study Completion: October 9, 2013
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

US (1)