Healthy VolunteerPhase 1NCT03803644
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects
A Phase 1 study testing CC-92480 in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 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 Volunteer
- What is being tested?
- CC-92480
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2018to 28 May 2019
- 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
- Subjects must satisfy the following criteria to be enrolled in the study:
- Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/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.
- Be a healthy male or female of non-childbearing potential of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and PE.
- Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Subjects in Clinical Trials.
- For males: Agree to use barrier contraception not made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) 1 while on study medication, and for at least 3 months 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 a plasma follicle-stimulation hormone [FSH] level of > 40 IU/L at screening).
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- Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
- No clinically significant laboratory test results as determined by the investigator.
- At the screening visit, must be afebrile, with supine systolic BP: 90 to 140 mmHg, supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 90 bpm. Eligibility criteria for vital signs performed during check-in and/or predose on Day 1 will be at the discretion of the Investigator. Repeat vital signs may be measured at Investigator discretion.
- Must have a normal or clinically-acceptable 12-lead ECG at screening. Male subjects must have a corrected QT interval using Fridericia's formula (QTcF) value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.
- Subject must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 subjects only.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- History of any clinically significant and relevant neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
- Any condition that 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.
- Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
- Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
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- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
- 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 [DSM]) 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 DSM) within 2 years before dosing, or positive alcohol screen.
- Known to have serum hepatitis; known to be a carrier of the hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody (anti-HBc), or hepatitis C antibody (HCV Ab); have a positive result to the test for hepatitis B or hepatitis C virus at screening or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening. Subjects whose results are compatible with prior immunization against hepatitis B may be included at the discretion of the Investigator.
- Exposure 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).
- Use of tobacco- or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).
- 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.
About this study
Official title: A Phase 1, Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dosing of CC-92480 and to Explore the Effect of Food on the Bioavailability of CC-92480 in Healthy Subjects
This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects.
Part 1:
Read more
Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule.
Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects.
- Conditions
- Healthy Volunteer
- Being tested
- CC-92480
- Keywords
- Healthy Subjects, CC-92480, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-92480Drug
Part 1 dose escalation
CC-92480Drug
CC-92480
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-92480 - Part 1 | Experimental | dose escalation Receives: Drug: CC-92480 |
| Administration of CC-92480 under fasted conditions - Part 2 | Experimental | Food effect Receives: Drug: CC-92480 |
| Administration of CC-92480 under fed conditions - Part 2 | Experimental | food effect Receives: Drug: CC-92480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics- Cmax Part 1
Maximum plasma concentration of drug
Measured: Day 1
Pharmacokinetics- Tmax Part 1
Time to maximum plasma concentration
Measured: Day 1
Pharmacokinetics- AUC0-∞ Part 1
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-t Part 1
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-24 Part 1
Area under the plasma concentration-time curve from time zero to 24 hours postdose
Measured: Up to 24 hours after dose administration
Pharmacokinetics- AUC-t½ Part 1
Terminal half-life
Measured: Up to 72 hours after dose administration
Pharmacokinetics- CL/F Part 1
Apparent total plasma clearance
Measured: Up to 72 hours after dose administration
Pharmacokinetics- Vz/F Part 1
Apparent total volume of distribution
Measured: Up to 72 hours after dose administration
Pharmacokinetics- Cmax Part 2
Maximum plasma concentration of drug
Measured: Day 1
Pharmacokinetics- Tmax Part 2
Time to maximum plasma concentration
Measured: Day 1
Pharmacokinetics- AUC0-∞ Part 2
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-t Part 2
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-24 Part 2
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Measured: Up to 24 hours after dose administration
Pharmacokinetics- AUC-t½ Part 2
Terminal half-life
Measured: Up to 72 hours after dose administration
Secondary outcomes (2)
Adverse Event(s)
Number of participants with adverse events
Measured: From enrollment until at least 28 days after completion of study treatment
Effect of CC-92480 on ECG parameters- Part 1
12-lead ECGs extracted from continuous (Holter) recordings will be used to assess effect of CC-92480 on Qt/QTc ECG parameters.
Measured: Up to day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start21 Dec 2018
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803644
- Sponsor's protocol ID
- CC-92480-CP-001
- Other IDs
- U1111-1224-6768
- Status last verified
- May 2020
- First submitted
- 17 Dec 2018
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Burnett J, Sychterz C, Katz J, Shakeel F, Silva J, Chen W, Shahane A, Wang X, Lamba M, Gaudy A. Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study. Clin Pharmacol Ther. 2026 Mar;119(3):641-650. doi: 10.1002/cpt.70082. Epub 2025 Oct 7.
PubMed 41058119Wu F, Liu L, Gaudy A, Wang X, Carayannopoulos L, Pourdehnad M, Lamba M. Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC-92480), a novel cereblon E3 ligase modulator. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1473-1484. doi: 10.1002/psp4.13024. Epub 2023 Sep 13.
PubMed 37705327
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. 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 Single Ascending Dosing of CC-92480 and to Explore the Effect of Food on the Bioavailability of CC-92480 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03803644
- Acronym / sponsor ID
- CC-92480-CP-001
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Subjects, CC-92480, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 14 Jan 2019 (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 two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects.
Part 1:
Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule.
Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of CC-92480 - Part 1 | Experimental | Drug: CC-92480dose escalation |
| Administration of CC-92480 under fasted conditions - Part 2 | Experimental | Drug: CC-92480Food effect |
| Administration of CC-92480 under fed conditions - Part 2 | Experimental | Drug: CC-92480food effect |
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 form (ICF) prior to any study-related assessments/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.
- Be a healthy male or female of non-childbearing potential of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and PE.
- Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Subjects in Clinical Trials.
- For males: Agree to use barrier contraception not made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) 1 while on study medication, and for at least 3 months 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 a plasma follicle-stimulation hormone [FSH] level of > 40 IU/L at screening).
Key exclusion criteria (15 listed)
- History of any clinically significant and relevant neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
- Any condition that 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.
- Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
- Use of 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-92480Part 1 dose escalation | Drug | Administration of CC-92480 - Part 1 |
| CC-92480CC-92480 | Drug | Administration of CC-92480 under fasted conditions - Part 2, Administration of CC-92480 under fed conditions - Part 2 |
Primary outcome
Pharmacokinetics- Cmax Part 1
Time frame: Day 1
Maximum plasma concentration of drug
Pharmacokinetics- Tmax Part 1
Time frame: Day 1
Time to maximum plasma concentration
Pharmacokinetics- AUC0-∞ Part 1
Time frame: Up to 72 hours after dose administration
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics- AUC0-t Part 1
Time frame: Up to 72 hours after dose administration
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Pharmacokinetics- AUC0-24 Part 1
Time frame: Up to 24 hours after dose administration
Area under the plasma concentration-time curve from time zero to 24 hours postdose
Pharmacokinetics- AUC-t½ Part 1
Time frame: Up to 72 hours after dose administration
Terminal half-life
Pharmacokinetics- CL/F Part 1
Time frame: Up to 72 hours after dose administration
Apparent total plasma clearance
Pharmacokinetics- Vz/F Part 1
Time frame: Up to 72 hours after dose administration
Apparent total volume of distribution
Pharmacokinetics- Cmax Part 2
Time frame: Day 1
Maximum plasma concentration of drug
Pharmacokinetics- Tmax Part 2
Time frame: Day 1
Time to maximum plasma concentration
Pharmacokinetics- AUC0-∞ Part 2
Time frame: Up to 72 hours after dose administration
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics- AUC0-t Part 2
Time frame: Up to 72 hours after dose administration
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Pharmacokinetics- AUC0-24 Part 2
Time frame: Up to 24 hours after dose administration
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Pharmacokinetics- AUC-t½ Part 2
Time frame: Up to 72 hours after dose administration
Terminal half-life
2 secondary outcomes
Adverse Event(s)
Time frame: From enrollment until at least 28 days after completion of study treatment
Effect of CC-92480 on ECG parameters- Part 1
Time frame: Up to day 2
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 7 May 2020.
- Derived from this study: PubMed 41058119Burnett J, Sychterz C, Katz J, Shakeel F, Silva J, Chen W, Shahane A, Wang X, Lamba M, Gaudy A. Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study. Clin Pharmacol Ther. 2026 Mar;119(3):641-650. doi: 10.1002/cpt.70082. Epub 2025 Oct 7.
- Derived from this study: PubMed 37705327Wu F, Liu L, Gaudy A, Wang X, Carayannopoulos L, Pourdehnad M, Lamba M. Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC-92480), a novel cereblon E3 ligase modulator. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1473-1484. doi: 10.1002/psp4.13024. Epub 2023 Sep 13.
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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.
Leon Carayannopoulos, 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-92480 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 15 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 7 May 2020. 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- Cmax Part 1 (time frame: Day 1). The study lists 14 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 NCT03803644, which also lists 2 linked publications.
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 7 May 2020.