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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02348372 | Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects | PHASE1 | COMPLETED | 34 | — | — | Mar 31, 2011 | Jun 3, 2011 | Jun 22, 2017 | 1 | Australia |
| NCT01319006 | Relative Bioavailability Study for GSK1278863A | PHASE1 | COMPLETED | 30 | — | — | Feb 25, 2011 | Apr 18, 2011 | Jun 26, 2017 | 1 | United States |
| NCT00750256 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects | PHASE1 | COMPLETED | 36 | — | — | Jul 7, 2008 | Dec 12, 2008 | Jul 21, 2017 | 1 | United States |
Platelet Count , RBC Indices, WBC Differential, RBC Count, WBC Count, Lymphocytes, Reticulocyte Count, Hemoglobin, Hematocritm, BUN, Ptassium, AST, Total and direct bilirubin, Creatinine, Chloride, ALT, Uric Acid, Glucose, Total CO2, GGT, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, CPK, Iron Ferritin, TIBC
systolic and diastolic blood pressure and pulse rate
To determine the relative bioavailability of GSK1278863A after single oral doses of 100 mg GSK1278863A tablets with particle sizes of 13, 29 and 41um in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| GSK1278863A Placebo | PLACEBO_COMPARATOR | 5, 25 and 100 mg matched |
| GSK1278863A 10mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 25mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 50mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 100mg | EXPERIMENTAL | A round, biconvex, white film coated tablet |
| GSK1278863A 100mg (X90=13um) | EXPERIMENTAL | single dose |
| GSK1278863A 100mg (x90=29Um) | EXPERIMENTAL | single dose |
| GSK1278863 100mg (X90=41um) | EXPERIMENTAL | single dose |
| Cohorts | EXPERIMENTAL | This study will be a single-blind, randomized, placebo-controlled, dose-rising, single dose, parallel group study with 6 proposed Cohorts from 2mg to 450mg. |
| Name | Type | Description |
|---|---|---|
| GSK1278863A Placebo | DRUG | Matching size, shape and color |
| GSK1278863A | DRUG | A round, biconvex, white film coated tablet |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \>1.5xULN. * Healthy Male or female between 20 and 65 years of age inclusive, at the time of signing the informed consent. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception me...