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| ID | Type | Description | Link |
|---|---|---|---|
| H9H-MC-JBEI | Other Identifier | Eli Lilly and Company. | |
| 2015-005261-23 | EudraCT Number |
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The study involves a single dose of galunisertib taken by mouth by Japanese participants and non-Japanese participants. The study will evaluate the relationship between the effect of the study drug on the electrical activity of the heart, as measured by electrocardiogram (ECG) and how much of the study drug gets into the blood stream and how long it takes the body to remove it. Ths study will last about 42 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Galunisertib - 1 tablet | Experimental | Single oral dose of galunisertib in Japanese participants |
|
| Part A Galunisertib - 2 tablets | Experimental | Single oral dose of galunisertib in Japanese participants |
|
| Part B Galunisertib - 1 tablet | Experimental | Single oral dose of galunisertib in non-Japanese participants |
|
| Part B Galunisertib - 2 tablets | Experimental | Single oral dose of galunisertib in non-Japanese participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galunisertib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Change from Baseline in Fridericia-corrected QT Interval (QTcF) by Specific Galunisertib Concentrations | Baseline through 72 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Galunisertib | Predose through 72 hours after administration of study drug | |
| Pharmacokinetics: Time of Cmax (tmax) of Galunisertib | Predose through 72 hours after administration of study drug |
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Inclusion Criteria:
Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination.
Male participants: Must agree to use a reliable method of birth control for 12 weeks after receiving the dose of study drug, OR be at least 6 weeks post-vasectomy with documentation of sperm-free ejaculate.
Female participants: Women not of child-bearing potential may participate, and include those who are:
All female participants must test negative for pregnancy at screening.
Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²), inclusive at screening.
Have clinical laboratory test results within normal reference range.
Are able and willing to give signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Leeds | West Yorkshire |
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| ID | Term |
|---|---|
| C557799 | LY-2157299 |
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|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Galunisertib | Predose through 72 hours after administration of study drug |
| United Kingdom |