An Evaluation of the Effects of Roflumilast on Cardiac Repolarization, Pharmacokinetics, Safety, and Tolerability in Healthy Volunteers

*Please Note* The Study you are attempting to view was acquired from Takeda by AstraZeneca and was disclosed initially by Takeda per their Transparency Policies. More information regarding this study may be available by contacting [email protected].

A phase 1, single-center, randomized, placebo- and active-controlled, parallel group study in 2 cohorts, to assess the effects of multiple-dose orally administered roflumilast on cardiac repolarization as measured by electrocardiogram (ECG) parameters in healthy subjects, the pharmacokinetics (PK) of roflumilast and roflumilast N-oxide following multiple daily doses of 500 and 1000 μg; and the safety and tolerability of roflumilast 500, 750, and 1000 μg once daily (QD) multiple doses when gradually titrated.