Healthy VolunteersPhase 1NCT02234999
Radiolabeled Study of CC-122 in Healthy Subjects
A Phase 1 study testing CC-122 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects 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 Volunteers
- What is being tested?
- CC-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2014to 8 Oct 2014
- 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
- 1. Healthy adult male of any race and between 18 years of age to 55 years of age, inclusive, at the time of signing the informed consent document.
- 2. Understand and voluntarily sign an informed consent document before any study related assessments/procedures are performed.
- 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Must practice true abstinence or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and for at least 28 days following discontinuation of investigational product, even if he has undergone a successful vasectomy.
- 5. Must agree to abide by the CC 122 Pregnancy Prevention Risk Management Plan 6. Must have a body mass index between 18 and 33 kg/m2, inclusive, at screening.
- 7. Must be healthy as determined by the Investigator on the basis of medical history, physical exam, clinical laboratory test results, vital signs, and 12-lead electrocardiogram at screening:
- Must be afebrile (febrile is defined as ≥ 38.5°C or 101.3°F)
- Supine systolic blood pressure must be in the range of 90 to 140 mmHg, supine diastolic blood pressure must be in the range of 50 to 90 mmHg, and pulse rate must be in the range of 40 to 110 bpm
- Normal or clinically acceptable 12 lead electrocardiogram, with a QTcF value ≤ 430 msec
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 (including a known hypersensitivity to a member of the class of IMiDs®), or other major disorders.
- 2. Any condition, including the presence of clinically significant laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- 3. Any condition that confounds the ability to interpret data from the study. 4. Exposed to an investigational drug (new chemical entity) within 30 days preceding dose administration, or five half lives of that investigational drug, if known (whichever is longer).
- 5. Participation in more than one other radiolabeled investigational drug study within 12 months prior to check in.
- Note: The previous radiolabeled investigational drug must have been received more than 6 months prior to check in and the total planned exposure from this current study and the previous study must be within the recommended levels considered safe, per United States Code of Federal Regulations governing Protection of Human Subjects; radioactive drugs for certain research uses.
- 6. Exposure to significant radiation (for example, 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.
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- 7. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of dose administration.
- 8. Used any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of dose administration.
- 9. Used cytochrome P450 3A inducers and/or inhibitors (including St. John's wort) within 30 days of dose administration.
- 10. Received a live vaccination within 90 days of dose administration. 11. Has any surgical or medical conditions possibly affecting absorption, distribution, metabolism, and/or elimination, for example, bariatric procedure, or plans to have elective or medical procedures performed during the conduct of the trial. Prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study.
- 12. Donated blood or plasma within 8 weeks before dose administration to a blood bank or blood donation center.
- 13. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- 14. History of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive alcohol screen.
- 15. 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 HIV antibodies at screening.
- 16. Smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
- 17. Part of the clinical site staff personnel or family members of the clinical site staff.
- 18. History of less than one to two bowel movements per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc
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-122 in Healthy Male Subjects
To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects
Read the detailed description
This is a single-center, open-label study to evaluate the metabolism and excretion of [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected for analyses.
- Conditions
- Healthy Volunteers
- Being tested
- CC-122
- Keywords
- Pharmacokinetics, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
3mg [14C]-CC-122 will be administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| 3mg [14C]-CC-122 (Single Dose) | Experimental | Single oral capsule of 3mg [14C]-CC-122. given as a suspension under fasting conditions on Day 1 Receives: Drug: CC-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK)
Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total [14C]-radioactivity
Measured: Up to 12 days
Cumulative excretion of total [14C]-radioactivity in urine and feces (PK)
Urine and feces will be collected and analyzed for measurement of [14C]-radioactivity
Measured: Up to 12 days
Total [14C]-radioactivity whole blood-to-plasma ratios: PK
Blood samples will be collected and analyzed for measurement of [14C]-radioactivity
Measured: Up to 8 days
Metabolite profiling/characterization in select biological matrices-PK
Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization
Measured: Up to 12 dyas
Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK
Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate
Measured: Up to 12 days
Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate
Measured: Up to 12 days
Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.
Measured: Up to 12 days
Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate
Measured: Up to 12 days
Secondary outcomes (1)
The incidence, type, severity of adverse events (AE)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology
Measured: Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start23 Sep 2014
- Primary completion8 Oct 2014
- Study completion8 Oct 2014
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.
- 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward O'Mara, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234999
- Sponsor's protocol ID
- CC-122-CP-003
- Status last verified
- Nov 2019
- First submitted
- 5 Sep 2014
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
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, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]-CC-122 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02234999
- Acronym / sponsor ID
- CC-122-CP-003
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 8 Oct 2014 (actual)
- Study completion
- 8 Oct 2014 (actual)
- First posted
- 9 Sep 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 metabolism and excretion of [14C]-CC-122 in healthy male subjects
Detailed description
This is a single-center, open-label study to evaluate the metabolism and excretion of [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected for analyses.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3mg [14C]-CC-122 (Single Dose) | Experimental | Drug: CC-122Single oral capsule of 3mg [14C]-CC-122. given as a suspension under fasting conditions on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1. Healthy adult male of any race and between 18 years of age to 55 years of age, inclusive, at the time of signing the informed consent document.
- 2. Understand and voluntarily sign an informed consent document before any study related assessments/procedures are performed.
- 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Must practice true abstinence or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and for at least 28 days following discontinuation of investigational product, even if he has undergone a successful vasectomy.
- 5. Must agree to abide by the CC 122 Pregnancy Prevention Risk Management Plan 6. Must have a body mass index between 18 and 33 kg/m2, inclusive, at screening.
- 7. Must be healthy as determined by the Investigator on the basis of medical history, physical exam, clinical laboratory test results, vital signs, and 12-lead electrocardiogram at screening:
Key exclusion criteria (17 listed)
- 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies (including a known hypersensitivity to a member of the class of IMiDs®), or other major disorders.
- 2. Any condition, including the presence of clinically significant laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- 3. Any condition that confounds the ability to interpret data from the study. 4. Exposed to an investigational drug (new chemical entity) within 30 days preceding dose administration, or five half lives of that investigational drug, if known (whichever is longer).
- 5. Participation in more than one other radiolabeled investigational drug study within 12 months prior to check in.
- Note: The previous radiolabeled investigational drug must have been received more than 6 months prior to check in and the total planned exposure from this current study and the previous study must be within the recommended levels considered safe, per United States Code of Federal Regulations governing Protection of Human Subjects; radioactive drugs for certain research uses.
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-1223mg [14C]-CC-122 will be administered as a single dose | Drug | 3mg [14C]-CC-122 (Single Dose) |
Primary outcome
Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK)
Time frame: Up to 12 days
Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total [14C]-radioactivity
Cumulative excretion of total [14C]-radioactivity in urine and feces (PK)
Time frame: Up to 12 days
Urine and feces will be collected and analyzed for measurement of [14C]-radioactivity
Total [14C]-radioactivity whole blood-to-plasma ratios: PK
Time frame: Up to 8 days
Blood samples will be collected and analyzed for measurement of [14C]-radioactivity
Metabolite profiling/characterization in select biological matrices-PK
Time frame: Up to 12 dyas
Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization
Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK
Time frame: Up to 12 days
Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate
Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Time frame: Up to 12 days
Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate
Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Time frame: Up to 12 days
Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.
Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate
Time frame: Up to 12 days
Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate
1 secondary outcome
The incidence, type, severity of adverse events (AE)
Time frame: Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug
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.
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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.
Edward O'Mara, 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-122 in people with Healthy Volunteers, 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 8 inclusion and 17 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?
Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK) (time frame: Up to 12 days). 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?
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.