A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin

Ejaculation Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366664
• Other study ID #: CR018607
• Secondary ID: R096769PRE1005
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2011
• Last updated: October 3, 2014
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia

• a body mass index between 18 and 35 kg/m², inclusive

• a body weight of not less than 50 kg

• supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive

• and, diastolic blood pressure measurements no higher than 95 mmHg.

Exclusion Criteria:

• History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results

• symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)

• taking a medication that is known to cause orthostatic hypotension, other than terazosin

• and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ejaculation

Intervention

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 sequence 1
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between standing and supine blood pressure measurements		Days 1-2	Yes
Primary	Difference between standing and supine blood pressure measurements		Days 5-6	Yes
Secondary	Plasma concentrations of dapoxetine		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	No
Secondary	Plasma concentrations of dapoxetine metabolite desmethyldapoxetine		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	No
Secondary	Number and type of adverse events		Up to a Maximum of 26 Days	Yes
Secondary	Clinical laboratory test values		Up to a Maximum of 26 Days	Yes
Secondary	Physical examination findings		Up to a Maximum of 26 Days	Yes
Secondary	Vital sign measurements		Up to a Maximum of 26 Days	Yes

External Links

•   A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin