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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01114607 | A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | May 5, 2010 | Jun 29, 2010 | Jul 18, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment sequence ABCDE | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABCDE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. |
| Treatment sequence ABDEC | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABDEC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. |
| Treatment sequence ABECD | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABECD and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. |
| Treatment sequence ABCED | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABCED and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= a film coated tablet of GSK1605786 GSK formulation 500 mg once daily and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. |
| Treatment sequence ABDCE | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABDCE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. |
| Treatment sequence ABEDC | EXPERIMENTAL | Eligible subjects will be randomized in sequence ABEDC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. |
| Treatment sequence BACDE | EXPERIMENTAL | Eligible subjects will be randomized in sequence BACDE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. |
| Treatment sequence BADEC | EXPERIMENTAL | Eligible subjects will be randomized in sequence BADEC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. |
| Treatment sequence BAECD | EXPERIMENTAL | Eligible subjects will be randomized in sequence BAECD and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. |
| Treatment sequence BACED | EXPERIMENTAL | Eligible subjects will be randomized in sequence BACED and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. |
| Treatment sequence BADCE | EXPERIMENTAL | Eligible subjects will be randomized in sequence BADCE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. |
| Treatment sequence BAEDC | EXPERIMENTAL | Eligible subjects will be randomized in sequence BAEDC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. |
| Name | Type | Description |
|---|---|---|
| GSK1605786 ChemoCentryx: formulation A | DRUG | ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast. |
| GSK1605786 GSK: formulation B | DRUG | GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast. |
| GSK1605786 GSK direct-fill: formulation C | DRUG | GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast. |
| GSK1605786 GSK modified-process: formulation D | DRUG | GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast. |
| GSK1605786 GSK tablet: formulation E | DRUG | GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast. |
Inclusion Criteria: 1. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical hi...