Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEK | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Contraceptive (OC) | Experimental | Ethinyl estradiol and levonorgestrel administered as a single dose, orally |
|
| Lanabecestat | Experimental | Single oral dose of lanabecestat |
|
| Lanabecestat and OC | Experimental | A single oral dose of oral contraceptive and single daily doses of lanabecestat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol | PK: AUC of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) |
| PK: AUC of Levonorgestrel | PK: AUC of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) |
| PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol | PK: Cmax of Ethinyl Estradiol | Baseline though 120 hours after administration of the study drug (lanabecestat) |
| PK: Cmax of Levonorgestrel | PK: Cmax of Levonorgestrel | Baseline though 120 hours after administration of the study drug (lanabecestat) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female
Not provided
Not provided
Not provided
| 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. | Singapore | 138623 |
Not provided
| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D003276 | Contraceptives, Oral |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral Contraceptive | Drug | Administered orally |
|
|
| Singapore |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |