Healthy VolunteerPhase 1NCT03294603
Radiolabeled Study of CC-220 in Healthy Male Subjects
A Phase 1 study testing CC-220 and [14C] in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a single-center, open-label study to characterize the biotransformation and excretion of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- CC-220 and [14C]
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 16 Oct 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Subject is male.
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health, as determined by the Investigator based on a physical examination at screening.
- Subject agrees to abide by the requirements and restrictions outlined in the CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
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- Subject must agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or a female of childbearing potential (FCBP)1 while participating in the study and for at least 90 days following administration of CC-220, even if he has undergone a successful vasectomy.
- Subject has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count (ANC), and absolute lymphocyte count (ALC) must be above the lower limit of normal at screening.
- Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
- Subject has a normal or clinically acceptable 12-lead electrocardiogram (ECG), with a QTcF value ≤ 430 msec, at screening.
Who cannot join
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days prior to dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 14 days or 5 half-lives of that medication, whichever is longer, prior to dosing.
- Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.
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- Subject has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30 days prior to dosing. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inducers and/or inhibitors of CYP3A.
- Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure.
- Note: prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study.
- Subject donated blood or plasma within 8 weeks prior to dosing to a blood bank or blood donation center.
- Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years prior to dosing, or positive drug test reflecting consumption of illicit drugs.
- Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years prior to dosing, or positive alcohol test.
- Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Subject smokes > 10 cigarettes per day, or equivalent in other tobacco products (self-reported).
- Subject has received immunization with a live or live attenuated vaccine within 2 months prior to dosing or is planning to receive immunization with a live or live attenuated vaccine for 2 months following dosing.
- Subject participated in a radiolabeled drug study, where exposures are known to the Investigator, within the previous 4 months prior to check-in (Day -1); or participated in a radiolabeled drug study, where exposures are not known to the Investigator, within the previous 6 months prior to check-in (Day -1). The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.
- Subject was exposed to significant radiation (eg, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in (Day -1).
- History of less than 1 to 2 bowel movements per day.
- Subject is part of the study site personnel or a family member of the study site staff.
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, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of (14C)-CC-220 in Healthy Male Subjects
This is a single-center, open-label study to characterize the biotransformation and excretion of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the study site on Day -1, and will be domiciled at the study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling / characterization), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the study site on Day 10 following completion of the scheduled study procedures and satisfactory safety review. Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
- Conditions
- Healthy Volunteer
- Being tested
- CC-220, [14C]
- Keywords
- Healthy Volunteer, CC-220, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220Drug
1mg [14C]-CC-220 will be administered as a single dose
[14C]Radiation
Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity
| Study group | Role | What they receive |
|---|---|---|
| [14C]-CC-220 solution | Experimental | A single oral dose of 1 mg [14C]-CC-220 solution, containing approximately 1.4 μCi of radioactivity, will be administered on Day 1 under fasted conditions. Receives: Drug: CC-220; Radiation: [14C] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics -Total [14C]-Radioactivity (RA)
Total [14C]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.
Measured: Up to approximately Day 10
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Measured: Up to approximately Day 10
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma
Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]-CC-220 based on specific activity of the dose.
Measured: Up to approximately Day 10
Pharmacokinetics - metabolite profiling/characterization
Percentage of the administered dose attributed to CC-220 and metabolite(s), and the RA of [14C]-CC-220 and metabolite(s), as appropriate, will be estimated.
Measured: Up to approximately Day 10
Pharmacokinetics -Cmax
Observed maximum plasma concentration, provided sufficient data available
Measured: Up to approximately Day 10
Pharmacokinetics -AUC
Area under the concentration-time curve, provided sufficient data available
Measured: Up to approximately Day 10
Pharmacokinetics -Tmax
Time to Cmax, provided sufficient data available
Measured: Up to approximately Day 10
Pharmacokinetics -t1/2
Terminal elimination half-life, provided sufficient data available
Measured: Up to approximately Day 10
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse event
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start11 Sep 2017
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
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 Healthy VolunteerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294603
- Sponsor's protocol ID
- CC-220-CP-006
- Other IDs
- U1111-1202-3955
- Status last verified
- Oct 2017
- First submitted
- 22 Sep 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cheng Y, Wang X, Liu L, Silva J, Thomas M, Li Y. A Phase I, Open-Label, Mass Balance Study of [14C]-Iberdomide in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2024 May;49(3):355-365. doi: 10.1007/s13318-024-00886-4. Epub 2024 Mar 23.
PubMed 38521893
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of (14C)-CC-220 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03294603
- Acronym / sponsor ID
- CC-220-CP-006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, CC-220, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 27 Sep 2017 (actual)
- 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.
This is a single-center, open-label study to characterize the biotransformation and excretion of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the study site on Day -1, and will be domiciled at the study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling / characterization), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the study site on Day 10 following completion of the scheduled study procedures and satisfactory safety review. Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-CC-220 solution | Experimental | Drug: CC-220, Radiation: [14C]A single oral dose of 1 mg [14C]-CC-220 solution, containing approximately 1.4 μCi of radioactivity, will be administered on Day 1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Subject is male.
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health, as determined by the Investigator based on a physical examination at screening.
Key exclusion criteria (19 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days prior to dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 14 days or 5 half-lives of that medication, whichever is longer, prior to dosing.
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-2201mg [14C]-CC-220 will be administered as a single dose | Drug | [14C]-CC-220 solution |
| [14C]Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity | Radiation | [14C]-CC-220 solution |
Primary outcome
Pharmacokinetics -Total [14C]-Radioactivity (RA)
Time frame: Up to approximately Day 10
Total [14C]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.
Pharmacokinetics - Cumulative excretion of total [14C]-RA
Time frame: Up to approximately Day 10
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Pharmacokinetics - Total [14C]-RA whole blood-to-plasma
Time frame: Up to approximately Day 10
Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]-CC-220 based on specific activity of the dose.
Pharmacokinetics - metabolite profiling/characterization
Time frame: Up to approximately Day 10
Percentage of the administered dose attributed to CC-220 and metabolite(s), and the RA of [14C]-CC-220 and metabolite(s), as appropriate, will be estimated.
Pharmacokinetics -Cmax
Time frame: Up to approximately Day 10
Observed maximum plasma concentration, provided sufficient data available
Pharmacokinetics -AUC
Time frame: Up to approximately Day 10
Area under the concentration-time curve, provided sufficient data available
Pharmacokinetics -Tmax
Time frame: Up to approximately Day 10
Time to Cmax, provided sufficient data available
Pharmacokinetics -t1/2
Time frame: Up to approximately Day 10
Terminal elimination half-life, provided sufficient data available
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
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 25 Oct 2017.
- Derived from this study: PubMed 38521893Cheng Y, Wang X, Liu L, Silva J, Thomas M, Li Y. A Phase I, Open-Label, Mass Balance Study of [14C]-Iberdomide in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2024 May;49(3):355-365. doi: 10.1007/s13318-024-00886-4. Epub 2024 Mar 23.
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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.
Maria Palmisano, MD study director
Celgene
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 and [14C] in people with Healthy Volunteer, 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 19 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 25 Oct 2017. 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?
Pharmacokinetics -Total [14C]-Radioactivity (RA) (time frame: Up to approximately Day 10). The study lists 8 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 NCT03294603, 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 25 Oct 2017.