- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034773
3-part Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of CC-220 and Relative Bioavailability of a Formulated CC-220 Capsule
A Phase 1, Three-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC-220 and to Evaluate the Relative Bioavailability of a Formulated CC-220 Capsule in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Covance Clinical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 examination.
4. For males: Agree to use barrier contraception not made of natural (animal) membrane [e.g., 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).
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. Platelet count, absolute neutrophil count and absolute lymphocyte count must be above the lower limit of normal at the screening visit.
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.
9. Antitetanus immunoglobulin G titer ≥ 0.1 IU/mL to ensure prior exposure of tetanus toxoid. Note: This criterion only applies to those subjects who will be dosed once daily for 28 days.
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 CYP3A 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, e.g., 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 antibody, 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.
14. Tetanus vaccination within 5 years prior to the first dose administration. Note: This criterion only applies to those subjects who will be dosed once daily for 28 days.
15. Pneumococcal vaccination within 3 years prior to the first dose administration. Note: This criterion only applies to those subjects who will be dosed once daily for 28 days.
16. Any self-reported history of hypersensitivity to vaccinations to be administered in this study or hypersensitivity to latex. Note: This criterion only applies to those subjects who will be dosed once daily for 28 days.
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Placebo
|
Placebo will be administered once daily for up to 28 days
|
EXPERIMENTAL: CC-220 0.3mg x 14 days
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 1mg x 28 days
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 0.3mg x 28 days
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 1mg x a total of 14 days
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 0.3mg (once every 3 days for 14 days)
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 1mg (once every 7 days for 28 days)
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
EXPERIMENTAL: CC-220 1mg (formulated and reference capsules)
|
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
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
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to 7 months overall
|
Number of participants with adverse events
|
Up to 7 months overall
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentrations of CC-220 and its R-enantiomer in plasma
Time Frame: Up to 30 days per cohort
|
Blood samples will be collected at pre-specified times to determine levels of CC-220 and its R-enantiomer in plasma
|
Up to 30 days per cohort
|
Pharmacodynamic Assessmens
Time Frame: Up to 42 days per cohort
|
Blood samples will be collected at pre-specified times for pharmacodynamic assessments
|
Up to 42 days per cohort
|
Pharmacokinetics - Cmax
Time Frame: Up to 30 days
|
Maximum observed plasma concentration
|
Up to 30 days
|
Pharmacokinetics - tmax
Time Frame: Up to 30 days
|
Time to Cmax
|
Up to 30 days
|
Pharmacokinetics - AUCinf
Time Frame: Up to 30 days
|
Area under the plasma concentration-time curve from time zero extrapolated to infinity
|
Up to 30 days
|
Pharmacokinetics - AUCt
Time Frame: Up to 30 days
|
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
|
Up to 30 days
|
Pharmacokinetics - AUCtau
Time Frame: Up to 30 days
|
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
|
Up to 30 days
|
Pharmacokinetics - t1/2,z
Time Frame: Up to 30 days
|
Terminal-phase elimination half-life
|
Up to 30 days
|
Pharmacokinetics - CL/F
Time Frame: Up to 30 days
|
Apparent total plasma clearance when dosed orally
|
Up to 30 days
|
Pharmacokinetics - Vz/F
Time Frame: Up to 30 days
|
Apparent total volume of distribution when dosed orally, based on the terminal phase
|
Up to 30 days
|
Accumulation Ratio (RA)
Time Frame: Up to 30 days
|
Accumulation Ratio for Cmax and AUCtau
|
Up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daniel Weiss, MD, Celgene
- Principal Investigator: Debra Mandarino, MD, Covance
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CC-220-CP-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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