Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-92480-02 (Formulation A) with Placebo | Experimental | CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions. |
|
| CC-92480 (Formulation B)- fasted condition | Experimental | A single oral dose of CC-92480 (Formulation B) administered under fasted conditions. |
|
| CC-92480-02 (Formulation A) - fasted condition | Experimental | A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions. |
|
| CC-92480 (Formulation B) - Low-fat meal | Experimental | A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal). |
|
| CC-92480-02 (Formulation A) - high-fat meal | Experimental | A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-92480 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Cmax Part 1 | Maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- Tmax Part 1 | Time to maximum plasma concentration | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-∞Part 1 | Area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-t Part1 | Area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- t½ Part 1 | Terminal elimination half-life | Up to 96 hours after dosing |
| Pharmacokinetics- CL/F Part 1 | Apparent total plasma clearance | Up to 96 hours after dosing |
| Pharmacokinetics- Vz/F Part 1 | Apparent volume of distribution | Up to 96 hours after dosing |
| Pharmacokinetics- tlag Part 1 | Lag time between time of administration and start of absorption | Up to 96 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Cmax (high-fat meal) | Maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal) | Ratio of maximum plasma concentration of drug |
Not provided
Inclusion Criteria:
Participants 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 conducted.
Healthy adult female of nonchildbearing potential or male 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 Physical examination (PE).
Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
For males:
a. Practice true abstinence (which must be reviewed on a monthly basis, as applicable) or agree to use a 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) while on study medication, and for at 3 months after the last dose of study medication even if he has undergone a successful vasectomy.
For females:
Female participants 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 serum follicle-stimulation hormone (FSH) level of > 40 IU/L at screening.
Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
Clinical laboratory test results must be within the respective reference ranges; or if not, the results be clinically insignificant according to the Investigator's medical judgment.
Participant must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 participants only.
Exclusion Criteria:
The presence of any of the following will exclude a participant from enrollment:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 Clinic | Austin | Texas | 78744 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Oral |
|
| Pharmacokinetics- Cmax Part 2 | Maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2 | Ratio of maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-∞ Part 2 | Area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2 | Ratio of area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-t Part 2 | Area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2 | Area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- Tmax Part 2 | Time to maximum plasma concentration | Up to 96 hours after dosing |
| Pharmacokinetics- t½ Part 2 | Terminal elimination half-life | Up to 96 hours after dosing |
| Pharmacokinetics- CL/F Part 2 | Apparent total plasma clearance | Up to 96 hours after dosing |
| Pharmacokinetics- Vz/F Part 2 | Apparent volume of distribution | Up to 96 hours after dosing |
| Pharmacokinetics- tlag Part 2 | Lag time between time of administration and start of absorption | Up to 96 hours after dosing |
| Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-∞(high-fat meal) | Area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal) | Ratio of area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-t (high-fat meal) | Area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal) | Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- Tmax (high-fat meal) | Time to maximum plasma concentration | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-24 (high-fat meal) | Area under the plasma concentration-time curve from time zero to 24 hours post dose | Up to 96 hours after dosing |
| Pharmacokinetics- t½ (high-fat meal) | Terminal elimination half-life | Up to 96 hours after dosing |
| Pharmacokinetics- CL/F (high-fat meal) | Apparent total plasma clearance | Up to 96 hours after dosing |
| Pharmacokinetics- Vz/F (high-fat meal) | Apparent volume of distribution | Up to 96 hours after dosing |
| Pharmacokinetics- tlag (high-fat meal) | Lag time between time of administration and start of absorption | Up to 96 hours after dosing |
| Pharmacokinetics- Cmax (low-fat meal) | Maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal) | Ratio of maximum plasma concentration of drug | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-∞(low-fat meal) | Area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal) | Ratio of area under the plasma concentration-time curve from time zero to infinity | Up to 96 hours after dosing |
| Pharmacokinetics- AUC0-t (low-fat meal) | Area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal) | Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration | Up to 96 hours after dosing |
| Pharmacokinetics- Tmax (low-fat meal) | Time to maximum plasma concentration | Up to 96 hours after dosing |
| Pharmacokinetics- t½ (low-fat meal) | Terminal elimination half-life | Up to 96 hours after dosing |
| Pharmacokinetics- CL/F (low-fat meal) | Apparent total plasma clearance | Up to 96 hours after dosing |
| Pharmacokinetics- Vz/F (low-fat meal) | Apparent volume of distribution | Up to 96 hours after dosing |
| Pharmacokinetics- tlag (low-fat meal) | Lag time between time of administration and start of absorption | Up to 96 hours after dosing |
| Incidence of 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. | From enrollment until at least 28 days after completion of study treatment |