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This Article Full Text Full Text (PDF) All Versions of this Article: 0091270009333486v1 49/6/634    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Google Scholar Articles by Modi, N. B. Articles by Rivas, D. PubMed PubMed Citation Articles by Modi, N. B. Articles by Rivas, D. Social Bookmarking                         What's this?

Pharmacokinetic, Pharmacodynamic, and Electrocardiographic Effects of Dapoxetine and Moxifloxacin Compared With Placebo in Healthy Adult Male Subjects

From the Department of Clinical Pharmacology, ALZA Corporation, Mountain View, California (Dr Modi, Dr Gupta); Department of Clinical Research, ALZA Corporation, Mountain View, California (Dr Nath, Dr Staehr); and Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey (Dr Aquilina, Dr Rivas).

Selective serotonin reuptake inhibitors (SSRIs) may be associated with electrocardiographic effects. The electrocardiographic pharmacodynamics of dapoxetine, a short-acting SSRI being developed for the treatment of premature ejaculation, are compared with those of placebo and moxifloxacin (positive control) in 2 single-center, randomized, crossover studies in healthy men. In study 1, subjects receive 2 doses of dapoxetine 120 mg, given 3 hours apart; a single dose of moxifloxacin 400 mg; and 2 doses of placebo, given 3 hours apart. In study 2, subjects receive single doses of dapoxetine 60 mg, dapoxetine 120 mg, moxifloxacin 400 mg, and placebo. Moxifloxacin significantly increases QT and corrects QT intervals (QTc) compared with placebo in both studies (eg, Bazett-corrected QTc of 11.90 milliseconds [95% confidence interval, 2.68 to 21.11] and 5.06 [95% confidence interval, -2.26 to 12.38]). Dapoxetine 60, 120, and 240 mg do not prolong the QT/QTc interval and have no clinically significant electrocardiographic effects. Dapoxetine and moxifloxacin pharmacokinetics are similar to previous reports. Adverse events are generally mild in severity; nausea is the most common. The results demonstrate that dapoxetine does not have electrocardiographic effects at doses of 60, 120, and 240 mg.

Key Words: Dapoxetine • premature ejaculation • QT=interval

Address for reprints: David Rivas, MD, Johnson & Johnson Pharmaceutical Research & Development, 700 US Route 202, Raritan, NJ 08869; e-mail: DRivas1{at}prdus.jnj.com.

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