Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01372085 | Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702 | PHASE1 | COMPLETED | 29 | — | — | Jun 1, 2011 | Sep 1, 2011 | Jan 22, 2019 | 1 | Singapore |
The Cmax following a single oral dose of LY2584702 test formulation \[TF (tablet)\] or reference formulation \[RF (capsule)\] is reported.
| Arm | Type | Description |
|---|---|---|
| Part A: 25 mg RF | EXPERIMENTAL | A single 25 mg dose of LY2584702 RF |
| Part A: Placebo | PLACEBO_COMPARATOR | Placebo taken orally |
| Part B: Sequence 1 | EXPERIMENTAL | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 2 | EXPERIMENTAL | Placebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 3 | EXPERIMENTAL | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 4 | EXPERIMENTAL | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Name | Type | Description |
|---|---|---|
| LY2584702 Reference Formulation | DRUG | Administered orally |
| LY2584702 Test Formulation | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: Male participants: • Agree to use a reliable method of birth control during the study and for at least 1 month following the last dose of study drug Female participants: • Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectom...