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This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
This is a two part study to be conducted at a single study site. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate in a Screening phase, one baseline visit per period, one dosing phase per period, and follow-up telephone call.
In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-220 in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Period 1: CC-220 | Experimental | Single dose of 0.6mg CC-220 |
|
| Part 1, Period 2: itraconazole with CC-220 | Experimental | Multiple does of 200 mg itraconazole alone, with a single dose of 0.6 mg CC-220 plus itraconazole |
|
| Part 2, Period 1: CC-220 | Experimental | Single dose of 0.6mg CC-220 |
|
| Part 2, Period 2: rifampin with CC-220 | Experimental | Multiple doses of 600 mg rifampin alone, with a single dose of 0.6 mg CC-220 plus rifampin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-220 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Cmax | Maximum plasma concentration | Up to 96 hours |
| Pharmacokinetics- AUC∞ | Area under the plasma concentration from time zero extrapolated to infinity | Up to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 2 month |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
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 examination (PE) at screening.
Subject agrees to abide by the requirements and restrictions outlined in the CC-220 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 abstinence1 (which must be reviewed on a monthly basis 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)2 while participating in the study, during dose interruptions, and for at least 28 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.
1 True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 2 A female of childbearing potential (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).
9. Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
10. 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.
11. Subject has a normal or clinically acceptable 12-lead ECG (Electrocardiogram) 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 |
|---|---|---|
| Maria Palmisano, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32965548 | Derived | Gaudy A, Atsriku C, Ye Y, MacGorman K, Liu L, Xue Y, Surapaneni S, Palmisano M. Evaluation of iberdomide and cytochrome p450 drug-drug interaction potential in vitro and in a phase 1 study in healthy subjects. Eur J Clin Pharmacol. 2021 Feb;77(2):223-231. doi: 10.1007/s00228-020-03004-w. Epub 2020 Sep 23. |
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| ID | Term |
|---|---|
| C000624220 | iberdomide |
| D012293 | Rifampin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug |
|
| Itraconazole | Drug |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |