A Phase 1 interventional study of Treatment sequence 2 and Treatment sequence 1 in Ejaculation, sponsored by Janssen Research & Development, LLC. Completed at 6 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-07.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.
This is a multiple-center, randomized (participants are assigned to study drug by chance), multiple-dose, double-blind (neither physician nor participant knows the treatment assigned), placebo (inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled, 2-period crossover (participants may receive different interventions sequentially during the trial) study to assess the pharmacodynamics, pharmacokinetics, safety, and tolerability of dapoxetine when concomitantly administered in adult male participants who have been on a stable dose of terazosin or doxazosin for at least 6 weeks. Study drugs used will be terazosin (a drug given for the treatment of hypertension and benign prostatic hyperplasia) and dapoxetine (a new drug being studied for the treatment of premature ejaculation). This study consists of a screening phase followed by a double-blind, placebo-controlled treatment phase consisting of 2 treatment periods. Participants will remain on their prescribed dose of terazosin and participants taking doxazosin will be converted to terazosin using the protocol-defined dose conversion (including assessment of control of urinary symptoms and risk for urinary retention). Participants will be administered concomitant (at the same time) dapoxetine or placebo once daily. Blood samples for pharmacodynamic and pharmacokinetic measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation will be approximately 49 days. Participants will remain on their prescribed dose of terazosin (2 to 10 mg taken once daily by mouth) and will be administered daily by mouth concomitant dapoxetine 60 mg or placebo doses during 2 treatment periods (each 7 days in duration conducted in the study center). A period of up to 14 days will separate the treatment periods.
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Exclusion Criteria:
Treatment sequence 1 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days)
Drug: Treatment sequence 1
Treatment sequence 2 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days)
Drug: Treatment sequence 2
Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days)
Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days)
Difference between standing and supine blood pressure measurements
Time frame: Days 1-2
Difference between standing and supine blood pressure measurements
Time frame: Days 5-6
Plasma concentrations of dapoxetine
Time frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Plasma concentrations of dapoxetine metabolite desmethyldapoxetine
Time frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Number and type of adverse events
Time frame: Up to a Maximum of 26 Days
Clinical laboratory test values
Time frame: Up to a Maximum of 26 Days
Physical examination findings
Time frame: Up to a Maximum of 26 Days
Vital sign measurements
Time frame: Up to a Maximum of 26 Days
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC