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| ID | Type | Description | Link |
|---|---|---|---|
| J6M-MC-JSGJ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Treatment A Fasted | Experimental | Tersolisib administered orally. |
|
| Group 1 Treatment B High-Fat Meal | Experimental | Tersolisib administered orally. |
|
| Group 2 Treatment A Fasted | Experimental | Tersolisib administered orally. |
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| Group 2 Treatment C Low-Fat Meal | Experimental | Tersolisib administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tersolisib | Drug | Tersolisib administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib | Predose on Day 1 Through Day 28 | |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib | Predose on Day 1 Through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
History of a major surgical procedure within 30 days prior to screening.
Known allergies to tersolisib or related compounds.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa Clinic | Lenexa | Kansas | 66219 | United States | ||
| ICON Early Phase Services, LLC |
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|
| High-fat Meal | Other | High-fat Meal |
|
| Low-fat Meal | Other | Low-fat Meal |
|
| San Antonio |
| Texas |
| 78232 |
| United States |