A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin

NCT01366664 | Completed Phase 1

• 2 other identifiers: CR018607R096769PRE1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Ejaculation

Keywords

Premature Ejaculation; Selective Serotonin Reuptake Inhibitor; Dapoxetine; PRILIGY; Terazosin; Pharmacodynamic; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• Difference between standing and supine blood pressure measurements

  Days 1-2

• Difference between standing and supine blood pressure measurements

  Days 5-6

Secondary Outcomes (6)

• 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

• 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

• Number and type of adverse events

  Up to a Maximum of 26 Days

• Clinical laboratory test values

  Up to a Maximum of 26 Days

• Physical examination findings

  Up to a Maximum of 26 Days

Study Arms (2)

001

EXPERIMENTAL

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

002

EXPERIMENTAL

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

Interventions

Treatment sequence 2 DRUG

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)

002

Treatment sequence 1 DRUG

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)

001

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

Unknown Facility

Anniston, Alabama, United States

Location

Unknown Facility

Tempe, Arizona, United States

Location

Unknown Facility

Costa Mesa, California, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Related Links

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

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

US (6)