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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1203-1818 | Registry Identifier | WHO |
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This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only.
Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2.
Part 1: On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of each study period, each subject will receive 1 of 2 treatments according to the sequence in which he or she is randomized.
In Part 2, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-122 in Period 2.
In Part 3, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of fluvoxamine plus one dose of fluvoxamine with CC-122 in Period 2.
In Part 4, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-122 in Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-122 Alone under fasted conditions | Experimental | Single oral dose of 3 mg CC-122 administered alone under fasted conditions |
|
| CC-122 plus Itraconazole | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of itraconazole. |
|
| CC-122 plus Fluvoxamine | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of fluvoxamine. |
|
| CC-122 plus Rifampin | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of rifampin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-122 | Drug | CC-122 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic- Cmax | Observed maximum plasma concentration | up to approximately 1 month |
| Pharmacokinetic- AUC 0-∞ | Area under the plasma concentration-time curve calculated from time zero extrapolated to infinity | up to approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of subjects with adverse event | From enrollment until at least 28 days after completion of treatment |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
Subject is ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Subject is in good health as determined by a physical exam at screening.
Subject agrees to abide by the requirements and restrictions outlined in the CC-122 Pregnancy Prevention Plan for Subjects in Clinical Trials.
Female subjects NOT of childbearing potential must:
a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
Male subjects must:
a. Practice true abstinence2 (which must be reviewed on a monthly basis, as applicable, and source documented) 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 female of childbearing potential (FCBP)3 while participating in the study, during dose interruptions, and for at least 90 days after the last dose of Investigational Product (IP), even if he has undergone a successful vasectomy.
Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
Subject has clinical laboratory safety test results that are within normal limits or
- considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
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 Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 Clinic | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C000602306 | 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione |
| D017964 | Itraconazole |
| D016666 | Fluvoxamine |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | CYP3A Inhibitor |
|
| Fluvoxamine | Drug | CYP1A2 Inhibitor |
|
| Rifampin | Drug | CYP3A Inducer |
|
| D010879 |
| Piperazines |
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |