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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01334242 | A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects | PHASE1 | COMPLETED | 14 | — | — | Mar 1, 2011 | - | May 19, 2011 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| LX4211 | EXPERIMENTAL | 400 mg of LX4211 administered orally |
| Placebo | PLACEBO_COMPARATOR | Nonidentical placebo administered orally |
| Name | Type | Description |
|---|---|---|
| Schedule A | DRUG | Dosing 1 hour before breakfast |
| Schedule B | DRUG | Dosing 0.5 hour before breakfast |
| Schedule C | DRUG | Dosing immediately before breakfast |
| Schedule D | DRUG | Dosing immediately before lunch |
| Schedule E | DRUG | Split dose, dosing 1 hour before breakfast and dinner |
Inclusion Criteria: * Adults ≥18 and ≤55 years of age * Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm * Body mass index (BMI) ≥18 and ≤35 kg/sq m * Able to provide written informed consent Excl...