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| ID | Type | Description | Link |
|---|---|---|---|
| I4S-EW-HHCB | Other Identifier | Eli Lilly and Company |
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This is a two part study. Part A is a multiple-ascending dose study in up to 6 different groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will allow investigation of up to 6 different doses of LY2979165. The drug will be administered for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from Day -1 (the day before dosing) until Day 15.
Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12 subjects. The drug will be administered for a total of 14 days. In addition to the same assessments as would have been completed in Part A, subjects in Part B will also have cerebrospinal fluid samples taken from the lower lumbar region of their spine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2979165 Part A, Cohort 1 | Experimental | 20 mg LY2979165 administered orally, daily for 14 days |
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| LY2979165 Part A, Cohort 2 | Experimental | 60 mg LY2979165 administered orally, daily for 14 days |
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| LY2979165 Part A, Cohort 3 | Experimental | 100 mg LY2979165 administered, orally daily for 14 days |
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| LY2979165 Part A, Cohort 4 | Experimental | 150 mg LY2979165 administered orally, daily for 14 days |
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| LY2979165 Part B, Cohort 5 | Experimental | Dose to be determined by safety review of doses administered in Part A, administered, orally daily for 14 days |
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| Placebo | Placebo Comparator | Administered orally, daily for 14 days in a ratio of 3:1 in each Cohort of Part A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2979165 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically significant effects | Baseline to study completion (estimate of 5 months, study ran for 11 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, area under the concentration curve (AUC): Part A | predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose,up to 48 hours on and after day 14 | |
| Pharmacokinetics, maximum concentration (Cmax): Part A |
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Inclusion Criteria:
Exclusion Criteria:
Additional criteria for Part B:
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| LY2979165 Part A, Cohort 6 | Experimental | 250 mg LY2979165 administered orally, daily for 14 days |
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| LY2979165 Part A, Cohort 7 | Experimental | 400 mg LY2979165 administered orally, daily for 14 days |
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| placebo | Drug | Administered orally |
|
| predose, up 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14 |
| Pharmacokinetics, area under the concentration curve (AUC): Part B | predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14 |
| Pharmacokinetics, maximum concentration (Cmax): Part B | predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14 |
| Pharmacokinetics; maximum concentration (Cmax) for Cerebrospinal Fluid (CSF): Part B | Pre dose (baseline) and 9 hours post dose |
| Pharmacodynamics; maximum concentration (Cmax) for CSF: Part B | Pre dose (baseline) and 9 hours post dose |
| Singapore |