HealthyPhase 1NCT01733875
2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects
A Phase 1 study testing CC-220 0.03 mg, CC-220 0.1 mg and CC-220 0.3 mg in people with Healthy, run by Celgene at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CC-220 0.03 mg, CC-220 0.1 mg and CC-220 0.3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 9 Oct 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
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
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, Two-part Study 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
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.
- Conditions
- Healthy
- Being tested
- CC-220 0.03 mg, CC-220 0.1 mg, CC-220 0.3 mg, CC-220 1 mg, CC-220 2 mg
- Keywords
- Safety, Pharmacokinetics, Food effect, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220 0.03 mgDrug
A single dose of CC-220 0.03 mg will be administered orally once a day.
CC-220 0.1 mgDrug
A single dose of CC-220 0.1 mg will be administered orally once a day.
CC-220 0.3 mgDrug
A single dose of CC-220 0.3 mg will be administered orally once a day.
CC-220 1 mgDrug
A single dose of CC-220 1 mg will be administered orally once a day.
CC-220 2 mgDrug
A single dose of CC-220 2 mg will be administered orally once a day.
PlaceboDrug
A single dose of placebo will be administered orally once a day.
CC-220Drug
CC-220 4 mg will be administered orally once a day
CC-220Drug
CC-220 6 mg will be administered orally once a day
CC-220Drug
CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food
| Study group | Role | What they receive |
|---|---|---|
| CC-220 0.03 mg | Experimental | Not described Receives: Drug: CC-220 0.03 mg |
| CC-220 0.1 mg | Experimental | Not described Receives: Drug: CC-220 0.1 mg |
| CC-220 0.3 mg | Experimental | Not described Receives: Drug: CC-220 0.3 mg |
| CC-220 1 mg | Experimental | Not described Receives: Drug: CC-220 1 mg |
| CC-220 2 mg | Experimental | Not described Receives: 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. Receives: Drug: Placebo |
| CC-220 4 mg | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 6 mg | Experimental | Not described Receives: Drug: CC-220 |
| CC-220 1 mg (Part 2 only) | 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 study participants with Adverse Events
Measured: 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
Measured: Up to 3 days in each period
Secondary outcomes (11)
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
Measured: Up to 3 days
PK-Cmax
Cmax: Maximum observed plasma concentration
Measured: Up to 3 days
PK-Tmax
Time to Maximum Plasma Concentration
Measured: Up to 3 days
PK-AUC 0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 3 days
PK-AUC 0-t
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Up to 3 days
PK-t1/2,z
Terminal-phase elimination half-life
Measured: Up to 3 days
PK-CL/F
Apparent total plasma clearance when dosed orally
Measured: Up to 3 days
PK-Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Measured: Up to 3 days
PK-Ae48
Cumulative amount of drug excreted unchanged in urine through 48 hours postdose
Measured: Up to 3 days
PK-fe48
Cumulative percentage of the administered dose excreted unchanged in urine through 48 hours postdose
Measured: Up to 3 days
PK-CLr
Renal clearance
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start1 Nov 2012
- Primary completion9 Oct 2013
- Study completion9 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Weiss, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733875
- Sponsor's protocol ID
- CC-220-CP-001
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2012
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part Study 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
- ClinicalTrials.gov ID
- NCT01733875
- Acronym / sponsor ID
- CC-220-CP-001
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics, Food effect, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 9 Oct 2013 (actual)
- Study completion
- 9 Oct 2013 (actual)
- First posted
- 27 Nov 2012 (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 a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: PlaceboIn each arm, 6 subjects will receive a dose of CC-220 and 2 subjects will receive placebo depending on the randomization schedule. |
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- Must have a body mass index between 18 and 33 kg/m2 (inclusive).
Key exclusion criteria (13 listed)
- 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.
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-220 0.03 mgA single dose of CC-220 0.03 mg will be administered orally once a day. | Drug | CC-220 0.03 mg |
| CC-220 0.1 mgA single dose of CC-220 0.1 mg will be administered orally once a day. | Drug | CC-220 0.1 mg |
| CC-220 0.3 mgA single dose of CC-220 0.3 mg will be administered orally once a day. | Drug | CC-220 0.3 mg |
| CC-220 1 mgA single dose of CC-220 1 mg will be administered orally once a day. | Drug | CC-220 1 mg |
| CC-220 2 mgA single dose of CC-220 2 mg will be administered orally once a day. | Drug | CC-220 2 mg |
| PlaceboA single dose of placebo will be administered orally once a day. | Drug | Placebo |
| CC-220CC-220 4 mg will be administered orally once a day | Drug | CC-220 4 mg |
| CC-220CC-220 6 mg will be administered orally once a day | Drug | CC-220 6 mg |
| CC-220CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food | Drug | CC-220 1 mg (Part 2 only) |
Primary outcome
Adverse Events
Time frame: Up to 5 months overall
Number of study participants with Adverse Events
Concentrations of CC-220 and its R-enantiomer in plasma (Part 2 only)
Time frame: Up to 3 days in each period
Blood samples will be collected at pre-specified times to determine levels of CC-220 free base and its R-enantiomer in plasma
11 secondary outcomes
Concentrations of CC-220 and its R-enantiomer in plasma (Part 1 only)
Time frame: Up to 3 days
PK-Cmax
Time frame: Up to 3 days
PK-Tmax
Time frame: Up to 3 days
PK-AUC 0-∞
Time frame: Up to 3 days
PK-AUC 0-t
Time frame: Up to 3 days
PK-t1/2,z
Time frame: Up to 3 days
PK-CL/F
Time frame: Up to 3 days
PK-Vz/F
Time frame: Up to 3 days
PK-Ae48
Time frame: Up to 3 days
PK-fe48
Time frame: Up to 3 days
PK-CLr
Time frame: Up to 3 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 12 Nov 2019.
- Background: PubMed 29945920Schafer 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.
- Related InfoLink provided by the sponsor.
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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 Corporation
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 0.03 mg, CC-220 0.1 mg and CC-220 0.3 mg in people with Healthy, run by Celgene 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 11 inclusion and 13 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 12 Nov 2019. 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 5 months overall). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733875, which also lists 1 linked publication.
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 12 Nov 2019.