Healthy VolunteersPhase 1NCT04560738
A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants
A Phase 1 study testing [14C]-CC-92480 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of [14C]-CC-92480. 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?
- [14C]-CC-92480
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 13 May 2021
- 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
- Participants must satisfy the following criteria to be enrolled in the study:
- Participant is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Participant is male.
- Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant is in good health, as determined by the Investigator at the time of signing the ICF.
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- Participant agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
- Participant must practice true abstinence or 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 FCBP while participating in the study and for at least 90 days following administration of CC-92480, even if he has undergone a successful vasectomy. A FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
- Participant has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at the time of signing the ICF.
- Participant has clinical laboratory safety test results, including alanine aminotransferase (ALT)/aspartate aminotransferase (AST) results, that are within normal limits or considered not clinically significant by the Investigator.
- Platelet count and absolute lymphocyte count (ALC) must be above the lower limit of normal at screening.
- Absolute neutrophil counts (ANC) must be greater than 2500/microliter.
- Participant is afebrile, with supine systolic BP ≥ 90 and ≤ 140 mm Hg, supine diastolic BP ≥ 50 and ≤ 90 mm Hg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
- Participant has a normal or clinically acceptable 12-lead ECG, with a QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤ 430 msec, at screening.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participant has a history of chronic pruritus or clinically significant chronic dermatologic disorder.
- Participant has contraindication or intolerance to first-generation antihistamine medications.
- Participant has a history of benign ethnic neutropenia.
- Participant has a 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 as determined by the Investigator.
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- Participant has any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
- Participant has any condition that confounds the ability to interpret data from the study.
- Participant 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).
- Participant 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.
- Participant has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.
- Participant 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 (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
- Participant 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.
- Participant donated blood or plasma within 8 weeks prior to dosing to a blood bank or blood donation center.
- Participant 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.
- Participant 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.
- Participant 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 reactive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Participant has a history of smoking/use of tobacco or nicotine-containing products within 3 months prior to check-in (Day -1).
- Participant 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.
- Participant 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: less than 5000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.
- Participant 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.
- Participant 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 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 92480 in Healthy Male Subjects
This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of [14C]-CC-92480.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-CC-92480
- Keywords
- Healthy Volunteers, CC-92480, Healthy male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-CC-92480Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Administration of [14C]-CC-92480 | Experimental | [14C]-CC-92480 will be administered as an oral solution. A single oral dose of [14C]-CC-92480, containing approximately 2 μCi of radioactivity, will be administered on Day 1 under fasted conditions. Receives: Drug: [14C]-CC-92480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion of [14C]-RA
The total recovery of radioactivity (RA) will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Measured: Up to approximately 15 days
Pharmacokinetics -Tmax of total radioactivity, CC-92480 and its metabolites
Time to reach maximum total radioactivity or concentration of CC-92480 and its metabolites
Measured: Up to approximately 15 days
Pharmacokinetics - Cmax of total radioactivity, CC-92480 and its metabolites
Maximum total radioactivity or concentration of CC-92480 and its metabolites
Measured: Up to approximately 15 days
Pharmacokinetics - AUC0-t of total radioactivity, CC-92480 and its metabolites
Area under the concentration-time curve from time zero to the last measured time point
Measured: Up to approximately 15 days
AUC0-inf of total radioactivity, CC-92480 and its metabolites
Area under the concentration-time curve from time zero extrapolated to infinite time
Measured: Up to approximately 15 days
Pharmacokinetics - CL/F of total radioactivity, CC-92480 and its metabolites
Apparent oral clearance
Measured: Up to approximately 15 days
Pharmacokinetics - Vz/F of total radioactivity, CC-92480 and its metabolites
Apparent volume of distribution
Measured: Up to approximately 15 days
Pharmacokinetics - t1/2 of total radioactivity, CC-92480 and its metabolites
Terminal elimination half-life
Measured: Up to approximately 15 days
Metabolic profiling in urines and feces
The percentage of the administered dose attributed to CC-92480 and its metabolites in urine and feces
Measured: Up to approximately 15 days
Secondary outcomes (1)
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant 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 participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
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 posted23 Sep 2020
- Study start15 Oct 2020
- Primary completion13 May 2021
- Study completion13 May 2021
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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560738
- Sponsor's protocol ID
- CC-92480-CP-004
- Other IDs
- U1111-1257-8762
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. 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 92480 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04560738
- Acronym / sponsor ID
- CC-92480-CP-004
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, CC-92480, Healthy male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 23 Sep 2020 (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 be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of [14C]-CC-92480.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of [14C]-CC-92480 | Experimental | Drug: [14C]-CC-92480[14C]-CC-92480 will be administered as an oral solution. A single oral dose of [14C]-CC-92480, containing approximately 2 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 (14 listed)
- Participant is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Participant is male.
- Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant is in good health, as determined by the Investigator at the time of signing the ICF.
Key exclusion criteria (24 listed)
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participant has a history of chronic pruritus or clinically significant chronic dermatologic disorder.
- Participant has contraindication or intolerance to first-generation antihistamine medications.
- Participant has a history of benign ethnic neutropenia.
- Participant has a 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 as determined by the Investigator.
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 |
|---|---|---|
| [14C]-CC-92480Oral | Drug | Administration of [14C]-CC-92480 |
Primary outcome
Cumulative excretion of [14C]-RA
Time frame: Up to approximately 15 days
The total recovery of radioactivity (RA) will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Pharmacokinetics -Tmax of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Time to reach maximum total radioactivity or concentration of CC-92480 and its metabolites
Pharmacokinetics - Cmax of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Maximum total radioactivity or concentration of CC-92480 and its metabolites
Pharmacokinetics - AUC0-t of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Area under the concentration-time curve from time zero to the last measured time point
AUC0-inf of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Area under the concentration-time curve from time zero extrapolated to infinite time
Pharmacokinetics - CL/F of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Apparent oral clearance
Pharmacokinetics - Vz/F of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Apparent volume of distribution
Pharmacokinetics - t1/2 of total radioactivity, CC-92480 and its metabolites
Time frame: Up to approximately 15 days
Terminal elimination half-life
Metabolic profiling in urines and feces
Time frame: Up to approximately 15 days
The percentage of the administered dose attributed to CC-92480 and its metabolites in urine and feces
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 29 Nov 2021.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 [14C]-CC-92480 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 14 inclusion and 24 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 29 Nov 2021. 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?
Cumulative excretion of [14C]-RA (time frame: Up to approximately 15 days). The study lists 9 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 29 Nov 2021.