No Evidence of QT Prolongation With Supratherapeutic Doses of Aleglitazar
被引:2
|
作者:
Sturm, Stefan
论文数: 0引用数: 0
h-index: 0
机构:
F Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, SwitzerlandF Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
Sturm, Stefan
[1
]
Bentley, Darren
论文数: 0引用数: 0
h-index: 0
机构:
Roche Prod Ltd, pRED, Pharma Res & Early Dev, Welwyn Garden City AL7 3AY, Herts, EnglandF Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
Bentley, Darren
[3
]
Jordan, Paul
论文数: 0引用数: 0
h-index: 0
机构:
F Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Biostat, Basel, SwitzerlandF Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
Jordan, Paul
[2
]
Russell-Yarde, Fiona
论文数: 0引用数: 0
h-index: 0
机构:
FRY Med Commun Ltd, Royston, Herts, EnglandF Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
Russell-Yarde, Fiona
[4
]
Ruf, Thorsten
论文数: 0引用数: 0
h-index: 0
机构:
F Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, SwitzerlandF Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
Ruf, Thorsten
[1
]
机构:
[1] F Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Clin Pharmacol, Basel, Switzerland
[2] F Hoffmann La Roche & Cie AG, pRED, Pharma Res & Early Dev, Biostat, Basel, Switzerland
[3] Roche Prod Ltd, pRED, Pharma Res & Early Dev, Welwyn Garden City AL7 3AY, Herts, England
Aleglitazar is a dual peroxisome proliferator-activated receptor (PPAR)-alpha/gamma agonist in clinical development, designed to offer a balanced activation of PPAR-alpha and PPAR-gamma. A phase 2 trial has demonstrated improvements in dyslipidemia and glycemic control and reduction of cardiovascular risk markers in patients with type 2 diabetes mellitus treated with aleglitazar. This study evaluated whether supratherapeutic doses of aleglitazar affect cardiac repolarization, as detected by changes in the QT interval. Healthy subjects were randomized to receive single oral doses of placebo, 300 mu g aleglitazar, 3000 mu g aleglitazar, and 400 mg moxifloxacin, in 1 of 4 sequences. Triplicate 12-lead electrocardiogram measurements were recorded predose and regularly (0.75-72 hours) after each treatment. The primary outcome was measurement of QT interval using a study-specific correction factor for heart rate. Administration of aleglitazar (300 mu g and 3000 mu g) did not cause any significant QT prolongation and after aleglitazar treatment any mean increases from placebo were <5 msec, at all time points. There was a trend for aleglitazar to cause a small dose-dependent decrease in QT interval using a study-specific correction factor for heart rate. The incidence of adverse events was similar with aleglitazar (18%-20%) and placebo (26%). Single supratherapeutic doses of aleglitazar are not associated with prolongation of the QT interval corrected for heart rate.
机构:
Ontario Pharmacists Assoc, Drug Informat & Res Centre, Toronto, ON, CanadaOntario Pharmacists Assoc, Drug Informat & Res Centre, Toronto, ON, Canada