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
Not provided
Not provided
Not provided
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-223 | Experimental | CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2 |
|
| Ketokonazole | Active Comparator | Ketoconazole administration on study days 1 through 8 of Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-223 | Drug | CC-223 20 mg tablets |
| |
| Ketoconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | AUC-area under the plasma concentration-time curve; | up to 96 hours post dose |
| Pharmacokinetics | Cmax-maximum observed plasma concentration | up to 96 hours post dose |
| Pharmacokinetics | Tmax - Time to maximum observed plasma concentration | up to 96 hours post dose |
| Pharmacokinetics | t½ - terminal elimination half-life in plasma | up to 96 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of subjects with adverse events | Up to 28 days after last dose of study drug |
Not provided
Inclusion Criteria:
Must understand and voluntarily sign a written informed consent form before participation.
Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
- For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.
Must have a body mass index between 18 and 33 kilograms/meter squared.
Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
Must have a normal or clinically acceptable 12-lead electrocardiogram.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward O'Mara, MD | Celgene Corporation | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29297772 | Background | Tong Z, Narayanan R, Atsriku C, Nissel J, Li Y, Liu H, Wang X, Surapaneni S. Assessment of drug-drug interaction potential and PBPK modeling of CC-223, a potent inhibitor of the mammalian target of rapamycin kinase. Xenobiotica. 2019 Jan;49(1):54-70. doi: 10.1080/00498254.2018.1424377. Epub 2018 Jan 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000601736 | CC-223 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Ketoconazole 400 mg tablets |
|
|