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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1224-6768 | Registry Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-92480 - Part 1 | Experimental | dose escalation |
|
| Administration of CC-92480 under fasted conditions - Part 2 | Experimental | Food effect |
|
| Administration of CC-92480 under fed conditions - Part 2 | Experimental | food effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-92480 | Drug | Part 1 dose escalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Cmax Part 1 | Maximum plasma concentration of drug | Day 1 |
| Pharmacokinetics- Tmax Part 1 | Time to maximum plasma concentration | Day 1 |
| Pharmacokinetics- AUC0-∞ Part 1 | Area under the plasma concentration-time curve from time zero extrapolated to infinity | 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 | 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 | Up to 24 hours after dose administration |
| Pharmacokinetics- AUC-t½ Part 1 | Terminal half-life | Up to 72 hours after dose administration |
| Pharmacokinetics- CL/F Part 1 | Apparent total plasma clearance | Up to 72 hours after dose administration |
| Pharmacokinetics- Vz/F Part 1 | Apparent total volume of distribution |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(s) | Number of participants with adverse events | 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. |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Carayannopoulos, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance-Daytona Beach | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37705327 | Derived | Wu 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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| CC-92480 |
| Drug |
CC-92480 |
|
| Up to 72 hours after dose administration |
| Pharmacokinetics- Cmax Part 2 | Maximum plasma concentration of drug | Day 1 |
| Pharmacokinetics- Tmax Part 2 | Time to maximum plasma concentration | Day 1 |
| Pharmacokinetics- AUC0-∞ Part 2 | Area under the plasma concentration-time curve from time zero extrapolated to infinity | 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 | 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 | Up to 24 hours after dose administration |
| Pharmacokinetics- AUC-t½ Part 2 | Terminal half-life | Up to 72 hours after dose administration |
| Up to day 2 |