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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00988624 | A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine) | PHASE1 | COMPLETED | 20 | — | — | Oct 1, 2009 | Dec 1, 2009 | Jan 12, 2010 | 1 | United States |
| NCT00990613 | A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin | PHASE1 | COMPLETED | 19 | — | — | Oct 1, 2009 | Jan 1, 2010 | Feb 3, 2010 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | - |
| Period 2 | EXPERIMENTAL | - |
| Period 3 | EXPERIMENTAL | - |
| Period 4 | EXPERIMENTAL | - |
| Period 5 | EXPERIMENTAL | - |
| Cohort 1 | OTHER | - |
| Cohort 2 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Dimebon IR Tablet | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3. |
| Dimebon MR1 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3. |
| Dimebon MR2 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3. |
| Dimebon MR3 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3. |
| Dimebon MR4 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3. |
| Dimebon IR | DRUG | A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered. |
| Dimebon Transdermal | DRUG | A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site. |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, p...