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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01440478 | The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects | PHASE1 | COMPLETED | 30 | — | — | Sep 1, 2011 | Oct 1, 2011 | Oct 12, 2011 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| LY2140023 + ammonium chloride | EXPERIMENTAL | 1 g of ammonium chloride administered orally every 3 hours for 33 hours (totaling 12 doses) in combination with a single 80 mg dose of LY2140023 administered orally 17 hours after first dose of ammonium chloride (acidified urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| LY2140023 + sodium bicarbonate | EXPERIMENTAL | 4 g of sodium bicarbonate administered orally every 4 hours for 32 hours (totaling 9 doses) in combination with a single 80 mg dose of LY2140023 administered orally 18 hours after first dose of sodium bicarbonate (alkalized urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| LY2140023 | EXPERIMENTAL | A single 80 mg dose of LY2140023 administered orally (normal urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| Name | Type | Description |
|---|---|---|
| LY2140023 | DRUG | Administered orally |
| Ammonium chloride | DRUG | Administered orally |
| Sodium bicarbonate | DRUG | Administered orally |
Inclusion Criteria: * are overtly healthy males or females, as determined by medical history and physical examination * female subjects of childbearing potential, who test negative for pregnancy at screening. Male subjects/female subjects of childbearing potential/female subjects who have been ster...