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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01318980 | A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A | PHASE1 | COMPLETED | 14 | — | — | Sep 30, 2010 | Mar 11, 2011 | Aug 3, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Period 1 Cohort 1 - GSK2190915 100mg | EXPERIMENTAL | Period 1 - GSK2190915 100mg tablet. |
| Period 1 Cohort 2 - GSK2190915 100mg plus microtracer | EXPERIMENTAL | Period 1 - GSK2190915 100mg tablet plus \[14C\] radiolabelled GSK2190915 microtracer solution. |
| Period 2 GSK2190915 100mg to proximal small bowel | EXPERIMENTAL | 100mg of ground half 200mg GSK2190915 tablet administered to the proximal small bowel via Enterion capsule. |
| Period 3 GSK2190915 100 mg to distal small bowel | EXPERIMENTAL | 100mg of ground half 200mg GSK2190915 tablet administered to the distal small bowel via Enterion capsule. |
| Period 4 - GSK 100mg enteric-coated tablet | EXPERIMENTAL | 100mg enteric-coated GSK2190915 coated tablet. |
| Name | Type | Description |
|---|---|---|
| GSK2190915 100mg milled tablet | DRUG | Taken orally |
| [14C] radiolabelled GSK2190915 solution | DRUG | Microtracer solution |
| GSK2190915 100mg milled tablet administered to the proximal small bowel. | DRUG | Ground half of a 200mg tablet. Administered via Enterion capsule. |
| GSK2190915 100mg milled tablet administered to the distal small bowel. | DRUG | Ground half of a 200mg tablet. Administered via Enterion capsule. |
| GSK2190915 100mg enteric-coated tablet. | DRUG | Taken orally |
Inclusion Criteria: * Healthy females as determined by an experienced study physician, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and electrocardiogram (ECG). A subject with a clinical abnormality or laboratory parameter...