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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01953835 | A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 | PHASE1 | COMPLETED | 37 | — | — | Oct 4, 2013 | Mar 10, 2014 | Jun 23, 2021 | 1 | United States |
| NCT01687309 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender | PHASE1 | COMPLETED | 19 | — | — | Apr 30, 2012 | Jul 31, 2012 | May 25, 2018 | 1 | Belgium |
Blood samples will be collected to analyse PK parameters of Rosuvastatin including area under the plasma concentration-time curve from time zero to infinity \[AUC(0-inf)\], area under the plasma concentration-time curve from time zero to the last quantifiable concentration \[AUC(0-t)\] and the maximum observed plasma concentration (Cmax).
Blood samples will be collected to analyse PK parameters of Simvastatin including AUC(0-inf), AUC(0-t) and Cmax.
Blood samples will be collected to analyse PK parameters of GSK2586184 (standard and new formulation) including AUC(0-inf), area under the plasma concentration-time curve from time 0 to 24 hrs (AUC(0-24)), time to maximum observed plasma drug concentration (Tmax) and Cmax.
Blood samples will be collected to analyse PK parameters of GSK2586184 (new formulation, without-poloxamer) including AUC (0-inf), AUC(0-24), Tmax and Cmax.
Change in health of subjects
Change in clinical chemistry, hematology and urinalysis from baseline
Change in blood pressure, heart rate and body temperature outside normal range
Change in ECG parameters outside normal range
Change in plasma concentrations of GSK2586184
Change in 24h urine creatinine, albumin and PCR values outside normal range
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Cohort A is a single-sequence, open-label study in which each subject will receive Simvastatin 10 mg single dose oral tablet on Days 1 and 10, Rosuvastatin 10 mg single dose oral tablet on Days 3 and 12 and GSK2586184 standard formulation 400 mg twice daily oral tablet from Day 6 to Day 14 immediately after food. At Day 10 GSK2586184 and Simvastatin and at Day 12, GSK2586184 and Rosuvastatin will be co-administered. |
| Cohort B | EXPERIMENTAL | Cohort B is a three-way crossover study in which each subject will receive a single dose of GSK2586184 standard formulation 400 mg oral tablet with food and two doses of a new formulation of GSK2586184 400 mg oral tablet, once with food and once in a fasted state, on Day 1, 4 and 7 according to their treatment sequence, with a 3-day wash out between doses. |
| Cohort A fed session | OTHER | GSK2586184 800mg single dose with food |
| Cohort A fasted session | OTHER | GSK2586184 single dose without food |
| Cohort B active study medication | ACTIVE_COMPARATOR | GSK2586184 800mg single and twice daily dose for 13 days |
| Cohort B placebo | PLACEBO_COMPARATOR | Placebo-to-match single and twice daily dose for 13 days |
| Name | Type | Description |
|---|---|---|
| GSK2586184 standard formulation | DRUG | GSK2586184 standard formulation is a white film coated round biconvex 200 mg oral tablet. For cohort A, it is to be administered at 400 mg (200 mg x 2 tablets) twice daily from Day 6 to Day 14. For cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose after standard breakfast either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day wash out period. |
| Simvastatin | DRUG | Simvastatin 10 mg oral tablet is peach-coloured, oval-shaped tablets. It is to be administered orally as a single dose of 10 mg tablet on the mornings of Day 1 and Day 10. |
| Rosuvastatin | DRUG | GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period. |
| GSK2586184 new formulation | DRUG | GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period. |
| GSK2586184 800mg single and repeat dose | DRUG | GSK2586184 800mg single dose and then twice daily dosing for 13 days |
| Placebo-to-match GSK2586184 | DRUG | Placebo-to-match GSK2586184 |
| GSK2586184 single dose taken with food | OTHER | GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast |
| GSK2586184 single dose taken without food | OTHER | GSK2586184 single dose taken in a fasted state |
Inclusion Criteria: * Males and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. (Females are only eligible for Cohort A). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, ...