Healthy VolunteersPhase 1NCT02034773
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 study testing CC-220 in people with Healthy Volunteers, run by Celgene Corporation at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-220
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: 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
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
Read the detailed description
This is a 3-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 4 cohorts, each of which consists of a different dose level and/or dosing duration, with 8 or 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and the remaining subjects will receive placebo depending on the randomization schedule. In 2 of the cohorts, study drug will be administered once daily for a total of 14 days. In the other 2 cohorts, study drug will be administered once daily for 28 days. In one of the 28-day dosing cohorts, 2 vaccinations (tetanus toxoid adsorbed and pneumococcal vaccinations) will also be administered on Day 14 of the 28-day dosing period to help characterize the effect of CC-220 on antibody responses. Part 2 is a randomized, double-blind, placebo-controlled, parallel-group study to explore the effects of an alternative dosing schedule on the pharmacodynamics of CC-220. During the course of Part 2, 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 2 cohorts, each of which consists of a different dose level, with 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 3 subjects will receive placebo depending on the randomization schedule. The dosing frequency will be either once every 3 days for 14 days or once every 7 days for 28 days. Part 3 is a randomized, open-label, two-period, two-way crossover study to evaluate the relative bioavailability of one CC-220 formulated capsule, relative to two reference capsules, following a single oral dose of CC-220. During the course of Part 3, each subject will participate in a screening phase, a baseline phase, a treatment phase consisting of 2 periods, and a follow up visit. There will be one cohort consisting of a total of 12 subjects. In each study period, approximately 6 subjects will receive a single dose of CC-220 as one formulated capsule (test product) and approximately 6 subjects will receive a single dose of CC-220 as two reference capsules (reference product).
- Conditions
- Healthy Volunteers
- Being tested
- CC-220, Placebo
- Keywords
- Safety, Pharmacokinetics, Pharmacodynamics, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220Drug
CC-220 0.3mg will be administered once daily for 14 days
CC-220Drug
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220Drug
CC-220 0.3mg will be administered once daily for 28 days
CC-220Drug
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
PlaceboDrug
Placebo will be administered once daily for up to 28 days
CC-220Drug
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220Drug
CC-220 1mg (once every 7 days for 28 days)
CC-220Drug
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
| Study group | Role | What they receive |
|---|---|---|
| CC-220 0.3mg x 14 days | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 1mg x 28 days | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 0.3mg x 28 days | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 1mg x a total of 14 days | Experimental | Not described Receives: Drug: CC-220 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
| CC-220 0.3mg (once every 3 days for 14 days) | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 1mg (once every 7 days for 28 days) | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 1mg (formulated and reference capsules) | Experimental | Not described Receives: Drug: CC-220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with adverse events
Measured: Up to 7 months overall
Secondary outcomes (11)
Concentrations of CC-220 and its R-enantiomer in plasma
Blood samples will be collected at pre-specified times to determine levels of CC-220 and its R-enantiomer in plasma
Measured: Up to 30 days per cohort
Pharmacodynamic Assessmens
Blood samples will be collected at pre-specified times for pharmacodynamic assessments
Measured: Up to 42 days per cohort
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Measured: Up to 30 days
Pharmacokinetics - tmax
Time to Cmax
Measured: Up to 30 days
Pharmacokinetics - AUCinf
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 30 days
Pharmacokinetics - AUCt
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Up to 30 days
Pharmacokinetics - AUCtau
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Measured: Up to 30 days
Pharmacokinetics - t1/2,z
Terminal-phase elimination half-life
Measured: Up to 30 days
Pharmacokinetics - CL/F
Apparent total plasma clearance when dosed orally
Measured: Up to 30 days
Pharmacokinetics - Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Measured: Up to 30 days
Accumulation Ratio (RA)
Accumulation Ratio for Cmax and AUCtau
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Weiss, MD, Study director, CelgeneDebra Mandarino, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034773
- Sponsor's protocol ID
- CC-220-CP-002
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02034773
- Acronym / sponsor ID
- CC-220-CP-002
- Conditions
- Healthy Volunteers
- Keywords
- Safety, Pharmacokinetics, Pharmacodynamics, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a 3-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 4 cohorts, each of which consists of a different dose level and/or dosing duration, with 8 or 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and the remaining subjects will receive placebo depending on the randomization schedule. In 2 of the cohorts, study drug will be administered once daily for a total of 14 days. In the other 2 cohorts, study drug will be administered once daily for 28 days. In one of the 28-day dosing cohorts, 2 vaccinations (tetanus toxoid adsorbed and pneumococcal vaccinations) will also be administered on Day 14 of the 28-day dosing period to help characterize the effect of CC-220 on antibody responses. Part 2 is a randomized, double-blind, placebo-controlled, parallel-group study to explore the effects of an alternative dosing schedule on the pharmacodynamics of CC-220. During the course of Part 2, 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 2 cohorts, each of which consists of a different dose level, with 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 3 subjects will receive placebo depending on the randomization schedule. The dosing frequency will be either once every 3 days for 14 days or once every 7 days for 28 days. Part 3 is a randomized, open-label, two-period, two-way crossover study to evaluate the relative bioavailability of one CC-220 formulated capsule, relative to two reference capsules, following a single oral dose of CC-220. During the course of Part 3, each subject will participate in a screening phase, a baseline phase, a treatment phase consisting of 2 periods, and a follow up visit. There will be one cohort consisting of a total of 12 subjects. In each study period, approximately 6 subjects will receive a single dose of CC-220 as one formulated capsule (test product) and approximately 6 subjects will receive a single dose of CC-220 as two reference capsules (reference product).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| CC-220 0.3mg x 14 days | Experimental | Drug: CC-220 |
| CC-220 1mg x 28 days | Experimental | Drug: CC-220 |
| CC-220 0.3mg x 28 days | Experimental | Drug: CC-220 |
| CC-220 1mg x a total of 14 days | Experimental | Drug: CC-220 |
| Placebo | Experimental | Drug: Placebo |
| CC-220 0.3mg (once every 3 days for 14 days) | Experimental | Drug: CC-220 |
| CC-220 1mg (once every 7 days for 28 days) | Experimental | Drug: CC-220 |
| CC-220 1mg (formulated and reference capsules) | Experimental | Drug: CC-220 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-220CC-220 0.3mg will be administered once daily for 14 days | Drug | CC-220 0.3mg x 14 days |
| CC-220CC-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 1mg x 28 days |
| CC-220CC-220 0.3mg will be administered once daily for 28 days | Drug | CC-220 0.3mg x 28 days |
| CC-220CC-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 | CC-220 1mg x a total of 14 days |
| PlaceboPlacebo will be administered once daily for up to 28 days | Drug | Placebo |
| CC-220CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses) | Drug | CC-220 0.3mg (once every 3 days for 14 days) |
| CC-220CC-220 1mg (once every 7 days for 28 days) | Drug | CC-220 1mg (once every 7 days for 28 days) |
| CC-220CC-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 | Drug | CC-220 1mg (formulated and reference capsules) |
Primary outcome
Adverse Events
Time frame: Up to 7 months overall
Number of participants with adverse events
11 secondary outcomes
Concentrations of CC-220 and its R-enantiomer in plasma
Time frame: Up to 30 days per cohort
Pharmacodynamic Assessmens
Time frame: Up to 42 days per cohort
Pharmacokinetics - Cmax
Time frame: Up to 30 days
Pharmacokinetics - tmax
Time frame: Up to 30 days
Pharmacokinetics - AUCinf
Time frame: Up to 30 days
Pharmacokinetics - AUCt
Time frame: Up to 30 days
Pharmacokinetics - AUCtau
Time frame: Up to 30 days
Pharmacokinetics - t1/2,z
Time frame: Up to 30 days
Pharmacokinetics - CL/F
Time frame: Up to 30 days
Pharmacokinetics - Vz/F
Time frame: Up to 30 days
Accumulation Ratio (RA)
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weiss, MD study director
Celgene
Debra Mandarino, MD principal investigator
Covance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-220 in people with Healthy Volunteers, run by Celgene Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 7 months overall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.